med draft watch mfr report - oracle€¦ · mfr report # 1999s1000056 uf/dist report # qqq 3. sex x...
TRANSCRIPT
1. Patient Identifier
68 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000055
UF/Dist Report #
RT
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
09/30/1931 XFemale
Male
or
lbs
kgs
200
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Consumer reports that e developed a case of athlete's foot while taking Saspirin
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/12/1994 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
DIABETES
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1600 MG;QID;PO
3. Therapy dates
#1 01/05/1994 - 06/23/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 ARTHRITIS
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9101
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
METFORMIN Unknown - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
X consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/18/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
FOOT FUNGUSHeadache NOS
1. Name, address & phone #TILLITT
2. Health professional?
yes no
9. Mfr. report number
1999S1000055
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
47 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000056
UF/Dist Report #
QQQ
3. Sex
X
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/01/1951Female
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
consumer reports abdominal pain after taking saspirin.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
01/06/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 Unknown - Unknown
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9104
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
X consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/20/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
Abdominal pain upper
1. Name, address & phone #TILLITT
2. Health professional?
yes no
9. Mfr. report number
1999S1000056
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
40 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000057
UF/Dist Report #
EFG
3. Sex
X
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/01/1959Female
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
consumer reports abdominal pain after taking saspirin.Occult blood revealed probable gastric ulcer.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
X
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
01/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 01/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9101;
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
X consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
01/02/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Gastric ulcer
1. Name, address & phone #TILLITT
2. Health professional?
yes no
9. Mfr. report number
1999S1000057
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
30 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000058
UF/Dist Report #
PHSQ
3. Sex
X
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/01/1969Female
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient in study ICU-102 diagnosed with bleeding duoenal ulcer. Patient has a long history of duodenalulcer, currently in remission. Hospitalized and put on IV cimetidine.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
01/02/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
TEST NAME DATE RESULT UNIT
DUODENAL ULCERulcerpatient hasent taken a vacation in 20 years.
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN (SASPIRIN)
#2SASPIRIN (SASPIRIN)
2. Dose, frequency and route used
#1300 MG;QD;PO
#2Unknown
3. Therapy dates
#1 Unknown - Unknown
#2 Unknown - Unknown
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
#2
(indication) 5. Event abated after usestopped or dose reduced
#1
#2
yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
#2 Unknown #2 Unknown
8. Event reappeared afterreintroduction
#1
#2
yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
+
10. Concomitant medical products and therapy dates (exclude treatment of event)
ASPIRIN Unknown - Unknown ASPIRIN Unknown - Unknown ASPIRIN Unknown - Unknown ASPIRIN Unknown - Unknown
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
X foreign
X study
literature
X consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
02/07/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Duodenal ulcerHeadache NOS
1. Name, address & phone #
2. Health professional?
yes no
9. Mfr. report number
1999S1000058
3. Occupation 4. Initial reporter alsosent report to FDA
yes no unk
+
(if known)
Page 1 of 4
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000058
UF/Dist Report #
(give labeled strength & mfr/labeler, if known)1. Name
#3SASPIRIN (SASPIRIN)
#4SASPIRIN (SASPIRIN)
2. Dose, frequency and route used
#3Unknown
#4Unknown
3. Therapy dates
#3 Unknown - Unknown
#4 Unknown - Unknown
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#3
#4
(indication) 5. Event abated after usestopped or dose reduced
#3
#4
yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
Un#3 Unknown
7. Exp. DateUn#3 Unknown
(if known)
Un#4 Unknown Un
#4 Unknown
8. Event reappeared afterreintroduction
#3
#4
yes nodoesn'tapply
yes nodoesn'tapply
+
(if known)
C. Suspect Medication(s)
Page 2 of 4
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000058
UF/Dist Report #
(give labeled strength & mfr/labeler, if known)1. Name
#5SASPIRIN (SASPIRIN)
#6SASPIRIN (SASPIRIN)
2. Dose, frequency and route used
#5Unknown
#6Unknown
3. Therapy dates
#5 Unknown - Unknown
#6 01/01/2001 - Unknown
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#5
#6 headache
(indication)
+
5. Event abated after usestopped or dose reduced
#5
#6
yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
Un#5 Unknown
7. Exp. DateUn#5 Unknown
(if known)
Un#6 Unknown Un
#6 Unknown
8. Event reappeared afterreintroduction
#5
#6
yes nodoesn'tapply
yes nodoesn'tapply
(if known)
C. Suspect Medication(s)
Page 3 of 4
#6 SASPIRIN (SASPIRIN)headacheheadacheheadacheheadacheheadacheheadacheheadacheheadacheheadacheheadacheheadache
ASPIRIN Unknown - Unknown
C4. Diagnosis for use (indication) - Continued
C10. Concomitant medical products - Continued
DRAFT- Mfr. report # 1999S1000058
Page 4 of 4
FDA Facsimile Approval 06/23/98(NetForce)
NetForce, Inc.
1. Patient Identifier
20 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000059
UF/Dist Report #
EKG
3. Sex
X
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/04/1979Female
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
consumer reports vertigo at visit 5 15 minutes after taking saspirin.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/05/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 Unknown - Unknown
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
X consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/10/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Vertigo NEC
1. Name, address & phone #DR RUSSELL TILLITT345 CALIFORNIA STREET20TH FLOORSAN FRANCISCO, CA 94014
2. Health professional?
yes no
9. Mfr. report number
1999S1000059
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
38 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000060
UF/Dist Report #
QQAQ
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
05/12/1960 XFemale
Male
or
lbs
kgs70
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
DIZZINESS (DIZZINESS)NAUSEA (NAUSEA)DEHYDRATION (DEHYDRATION)VOMITING (VOMITING)DYSPEPSIA (DYSPEPSIA)The patient had been taking SASPIRIN for some time. Around January 17th, they began experiencing dizziness and nausea leading to vomiting and eventualdehydration. Patient was admitted to the hospital on the 19th, received was rehydrated after discontinuingmedication.CONFIRMATORY TESTS:The confirmatory tests looked fine, EKG was normal.
LAB TESTS:TEST NAME COLL. DATE ACTUAL VALUE UNITS LOW VALUE HIGH VALUEHBG 19-JAN-1999 100 MG/L 80 120 HCT 19-JAN-1999 120 MG/L 100 115
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
X death(mo/day/yr)
01/19/1999
X life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
01/17/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
The confirmatory tests looked fine, EKG was normal.TEST NAME DATE RESULT UNITHBG 19JAN1999 100 MG/L HCT 19JAN1999 120 MG/L
ANXIETY
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;BID;PO
3. Therapy dates
#1 12/14/1998 - 01/19/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 CHRONIC PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 X yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9406
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
PROZAC --/--/1989 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
01/19/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Dizziness (exc vertigo)NauseaDehydrationVomiting NOSDyspepsia
+
1. Name, address & phone #DR BRAD GALLIEN1234 WEST 34RD STREETHAPPYLAND, MO 74321Tel.-222-345-7890
2. Health professional?
X yes no
9. Mfr. report number
1999S1000060
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
Page 1 of 2
Headache NOS
G8. Adverse event term(s) - Continued
DRAFT- Mfr. report # 1999S1000060
Page 2 of 2
FDA Facsimile Approval 06/23/98(NetForce)
NetForce, Inc.
1. Patient Identifier
48 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000062
UF/Dist Report #
WSS
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/06/1951 XFemale
Male
or
lbs
kgs
160
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient on saspirin for angina developed hearing loss.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
X disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
ANGIOGRAM IN 1998 SHOWED MULTIPLE CORONARY ARTERY CONSTRICTIONS.
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1150 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 ANGINA PECTORIS
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9407
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
ASPIRIN 12/--/1999 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
08/12/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 2
8. Adverse event term(s)
Anaesthetic complicationneurological
1. Name, address & phone #DR. B JACKSON508 HILL STSAN FRANCISCO, CA 94114Tel.-00165443333333
2. Health professional?
X yes no
9. Mfr. report number
1999S1000062
3. Occupation
MD
4. Initial reporter alsosent report to FDA
X yes no unk
(if known)
1. Patient Identifier
42 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000063
UF/Dist Report #
TUY
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
12/31/1957 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
The patient had been taking SASPIRIN for some time. Then they started feeling ill.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
03/12/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Patient's EKG reflected extreme dehydration.
None
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;BID;PO
3. Therapy dates
#1 10/01/1998 - 03/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 CHRONIC PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 X yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9108
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
03/13/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
DehydrationVomiting NOS
1. Name, address & phone #DR BRAD GALLIEN1234 WEST 34RD STREETHAPPYLAND, MO 74321Tel.-222-345-7890
2. Health professional?
X yes no
9. Mfr. report number
1999S1000063
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
38 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000064
UF/Dist Report #
IKO
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
10/12/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
The patient had been taking SASPIRIN for some time. Then they started feeling ill. The patient died on the second day of hospitalization following failures to supress vomiting.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
X death(mo/day/yr)
03/18/1999
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
03/17/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Tests consistent with dehydration and ion depletion.
None
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;BID;PO
3. Therapy dates
#1 12/15/1998 - 03/17/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 CHRONIC PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
AAS-1234- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
PEPTO BISMAL 03/10/1999 - 03/17/1999
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
03/17/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
DehydrationVomiting NOS
1. Name, address & phone #DR BRAD GALLIEN1234 WEST 34RD STREETHAPPYLAND, MO 74321Tel.-222-345-7890
2. Health professional?
X yes no
9. Mfr. report number
1999S1000064
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
23 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000065
UF/Dist Report #
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/01/1976 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
The patient had been taking SASPIRIN for some time. Then they started feeling ill.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/19/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;BID;PO
3. Therapy dates
#1 10/01/1998 - 03/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 CHRONIC PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 X yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
AAS-1234- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/15/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Myocardial infarctionVomiting NOSHeadache NOS
1. Name, address & phone #DR BRAD GALLIEN1234 WEST 34RD STREETHAPPYLAND, MO 74321Tel.-222-345-7890
2. Health professional?
X yes no
9. Mfr. report number
1999S1000065
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
41 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000066
UF/Dist Report #
GT
3. Sex
X
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
09/23/1957Female
Male
or
lbs
kgs65
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient on saspirin for angina developed hearing loss.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
X disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/17/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
None
None
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN (SASPIRIN)
2. Dose, frequency and route used
#1150 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/17/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 ANGINA PECTORIS
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
X foreign
study
literature
consumer
X health professional
X user facility
X companyrepresentative
X distributor
other:
4.Date received by manufacturer (mo/day/yr)
06/17/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
Deafness NOS
1. Name, address & phone #DR. S DEBOIS508 HILL STPARIS
2. Health professional?
X yes no
9. Mfr. report number
1999S1000066
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
ASD-1234
1. Patient Identifier
48 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000067
UF/Dist Report #
WSS
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
06/01/1951 XFemale
Male
or
lbs
kgs
160
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
WSS, a 48 year old man who, developed chest pain characteristic of a myocardial infarction on June 1 and was hospitalized that day and started on saspirin. Patient had a difficult hospital course marked by heart failure beginning on June 2. Patient died on June 3. Autopsy confirmed the myocardial infaction.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
X life-threatening
X hospitalization - initial or prolonged X other: OTHER
X
congenital anomaly
X disability
required intervention to preventpermanent impairment/damage
X
3. Date of event
(mo/day/yr)
06/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Elevated CPK myocardial isoenzymes. ECG showed anterior site of infarction. Chest xray showed markedly dilated heart characteristic of failure. Swan Gantz cathether showed elevated end diastolic left ventricular pressure.
HYPERCHOLESTEROLEMIA
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/03/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 ANGINA
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
BENADRYL 05/01/1999 - 06/01/1999
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/22/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 2
8. Adverse event term(s)
Cardiac failure congestive
1. Name, address & phone #DR. ALFRED E JONES235 E 40TH STREETNYC, NY 10001Tel.-212-123-1234
2. Health professional?
X yes no
9. Mfr. report number
1999S1000067
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
36 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000068
UF/Dist Report #
GU
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
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In confidence
4. Weight
Date of birth:
or
05/22/1962 XFemale
Male
or
lbs
kgs
190
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
The patient had been taking SASPIRIN for 7 months in the clinical trial when they presented with jaundice at visit 14. Evaluation revealed hepatitis. Patient hospitalized.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
X
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;BID;PO
3. Therapy dates
#1 10/01/1998 - 05/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 CHRONIC PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 X yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
AAS-1234- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
TICLOPIDINE 01/--/1999 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/15/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
LIVER DYSFUNCTIONHepatitis NOSTEMPORARY BLINDNESS
1. Name, address & phone #DR BRAD GALLIEN1234 WEST 34RD STREETHAPPYLAND, MO 74321Tel.-222-345-7890
2. Health professional?
X yes no
9. Mfr. report number
1999S1000068
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
48 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000069
UF/Dist Report #
XOEE
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1950 XFemale
Male
or
lbs
kgs
100
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient reported nausea shortly after morning dose ofSaspirin. Nausea did not resolve after stopping drug. Patient began vomiting blood, hospitialized forobservation. Gastric ulcer discovered. Placed on cimetiding and released.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/03/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
X other:
123
4.Date received by manufacturer (mo/day/yr)
06/03/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
NauseaGastric ulcer
1. Name, address & phone #DR JONES235 E 40THNEW YORKNEW YORK10001
2. Health professional?
X yes no
9. Mfr. report number
1999S1000069
3. Occupation
MD
4. Initial reporter alsosent report to FDA
X yes no unk
(if known)
1. Patient Identifier
70 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000070
UF/Dist Report #
USG
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
02/04/1929 XFemale
Male
or
lbs
kgs
150
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient initially reported vertigo and drug was discontinued. Follow up data revealed that the patient also had a gastric ulcer.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
04/05/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/10/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
Vertigo NECGastric ulcer
1. Name, address & phone #DR JONES235 E 40THNEW YORKNEW YORK10001
2. Health professional?
X yes no
9. Mfr. report number
1999S1000070
3. Occupation
MD
4. Initial reporter alsosent report to FDA
X yes no unk
(if known)
TF-23231-SDF3
1. Patient Identifier
48 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000071
UF/Dist Report #
OWW
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1951 XFemale
Male
or
lbs
kgs
160
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
SYNCOPE (ANAPHYLACTOID REACTION)Patient received saspirin in physician's office for pain and developed syncope. Patient was rechallenged and developed hypotension. Initial reaction and rechallenge side effects are considered anaphylaxis reaction to saspirin. Patiently was initially reported by physician to have dizzyness, migraine and tinnitus that resolved. Patient is alsoinvolved in an IND study of saspirin and mohair.LAB TESTS:TEST NAME COLL. DATE ACTUAL VALUE UNITS LOW VALUE HIGH VALUEBLOOD SUGAR 04-JUN-1999 100 MMOL/L 10 150
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
X
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
TEST NAME DATE RESULT UNITBLOOD SUGAR 04JUN1999 100 MMOL/L
patient has a history of pennicillin allergy
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 06/01/1999 - 06/02/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 PAIN
(indication)
+5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 L12345
7. Exp. Date
#1 11/12/2000
(if known)
8. Event reappeared afterreintroduction
#1 X yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
epinephrine 06/03/1999 - 06/03/1999 MOHAIR 01/01/1999 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/05/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 2
8. Adverse event term(s)
Anaphylactic reaction
1. Name, address & phone #DR JONES235 E 40THNEW YORKNEW YORK10001
2. Health professional?
X yes no
9. Mfr. report number
1999S1000071
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
Page 1 of 2
#1 SASPIRINHEADACHEALLERGIES
C4. Diagnosis for use (indication) - Continued
DRAFT- Mfr. report # 1999S1000071
Page 2 of 2
FDA Facsimile Approval 06/23/98(NetForce)
NetForce, Inc.
1. Patient Identifier
48 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000072
UF/Dist Report #
XIWW
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1951 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient on Saspirin for 5 months began to vomit bloodand was hospitalized.Follow up data recived on 10 Jun noted that the patient had been placed on cimetidine IV for 3 days, and was recovering. Was given a prescription for PO cimetidine and released.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/03/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/10/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
HEMATOEMESIS
1. Name, address & phone #DR JONES235 E 40THNEW YORKNEW YORK10001
2. Health professional?
X yes no
9. Mfr. report number
1999S1000072
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
47 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000073
UF/Dist Report #
WIZS
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1952 XFemale
Male
or
lbs
kgs
160
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
ACNE (Acne NOS)Patient developed Acne after 5 months of treatment with Saspirin.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/03/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/04/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Acne NOS
1. Name, address & phone #DR JONES235 E 40THNEW YORKNEW YORK10001
2. Health professional?
X yes no
9. Mfr. report number
1999S1000073
3. Occupation
MD
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
48 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000074
UF/Dist Report #
WWO
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1951 XFemale
Male
or
lbs
kgs
165
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient had drop in serum hematocrit from 52 to 18 over a two month period and was given outpatient diagnostic tests. All tests were negative. Patientwas found to be taking Saspirin on his own unbeknown to referring physician. Saspirin was discontinued.Follow up received on june 10 contained the lab result report hard copy. all tests negative.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/03/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
hemoglobin dropped from 18 to 12g/dl
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 01/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 Xyes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 Xyes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/10/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
Anaemia NOS
1. Name, address & phone #DR JONES235 E 40THNEW YORKNEW YORK10001
2. Health professional?
X yes no
9. Mfr. report number
1999S1000074
3. Occupation
MD
4. Initial reporter alsosent report to FDA
X yes no unk
(if known)
1. Patient Identifier
60 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000075
UF/Dist Report #
TUI
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
02/04/1939 XFemale
Male
or
lbs
kgs
115
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Consumers wife reports spouse has persistent cough after taking saspirin. It is driving her crazy.Follow up received on 10 jun-1999 revealed that the spouse got tired of the cough and shot him.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/04/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1300 MG;QD;PO
3. Therapy dates
#1 Unknown - Unknown
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
literature
X consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/10/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
Cough
1. Name, address & phone #
2. Health professional?
yes no
9. Mfr. report number
1999S1000075
3. Occupation 4. Initial reporter alsosent report to FDA
yes no unk
(if known)
1. Patient Identifier
69 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000080
UF/Dist Report #
GG
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
11/01/1929 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
This study reported in JAMA was a phase 3 investigation of saspirin versus placebo in the treatment of secondary stroke. Safety data were reported in tabular format. Additionally several patients were picked at random, including this patient to describe certain safety events as case studies. These case data are reproduced in this report. The article is attached.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/20/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
the EKG appeared normalTEST NAME DATE RESULT UNITHCT 100 MG/L
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 05/15/1999 - 06/20/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
X literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/21/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Dizziness (exc vertigo)Headache NOSNausea
1. Name, address & phone #GALLIEN
2. Health professional?
X yes no
9. Mfr. report number
1999S1000080
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
39 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000081
UF/Dist Report #
GG
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
This study reported in JAMA was a phase 3 investigation of saspirin versus placebo in the treatment of secondary stroke. Safety data were reported in tabular format. Additionally several patients were picked at random, including this patient to describe certain safety events as case studies. These case data are reproduced in this report. The article is attached.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/10/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 06/01/1999 - 06/10/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
X literature
consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/26/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
initial X follow-up # 1
8. Adverse event term(s)
Anaemia NOS
1. Name, address & phone #WARD
2. Health professional?
yes no
9. Mfr. report number
1999S1000081
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
Unknown
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000083
UF/Dist Report #
EE
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
This study reported in JAMA was a phase 3 investigation of saspirin versus placebo in the treatment of secondary stroke. Safety data were reported in tabular format. Additionally several patients were picked at random, including this patient to describe certain safety events as case studies. These case data are reproduced in this report. The article is attached.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
X death(mo/day/yr)
06/12/1999
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/12/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
ANXIETYHYPERREACTIVITYPATIENT IS/WAS EXTREMELY STRESSED OUT
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1Unknown;PO
3. Therapy dates
#1 05/12/1999 - 06/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9104
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
study
X literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/12/1999
5.
(A)NDA # 12-345
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
SPONTANEOUS COMBUSTION
1. Name, address & phone #BRAD GALLIEN
2. Health professional?
X yes no
9. Mfr. report number
1999S1000083
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
39 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000086
UF/Dist Report #
EE
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
140
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient EE in clinical trial QA center 101 was randomized to Saspirin. Took a tablet from new supplyof Saspirin and went into anaphylactic shock. Relatives called 911, paramedics treated with epinephrine.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
X
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/20/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
TEST NAME DATE RESULT UNITCBC
ANXIETY MEETS DSM IV CRITERIA FOR GADHISTORY OF PENNICLLIN ALLERGY
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;BID;PO
3. Therapy dates
#1 06/18/1999 - 06/20/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 ACUTE PAIN
(indication) 5. Event abated after usestopped or dose reduced
#1 X yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 SAS-9101
7. Exp. Date
#1 07/31/2000
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
XANAX 10/10/1995 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/21/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Anaphylactic reactionUrticaria NOS
1. Name, address & phone #B GALLIEN3401 HILLVIEWPALO ALTOCA94303
2. Health professional?
X yes no
9. Mfr. report number
1999S1000086
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
39 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000088
UF/Dist Report #
ASD
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
05/12/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient received Saspirin from a new clinical supply at visit 10. Went into apparent anaphylactic shock 5 minutes after dosing. Treatedwith epinephrine and dropped from study.
1. X Adverse event and/or X Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
hospitalization - initial or prolonged other:
X
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/20/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
ALLERGIC TO PENNICILLIN.
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN (SASPIRIN)
2. Dose, frequency and route used
#1100 MG;QD;PO
3. Therapy dates
#1 06/10/1999 - 06/20/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
X foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/20/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Anaphylactic reaction
1. Name, address & phone #BRAD GALLIEN
2. Health professional?
X yes no
9. Mfr. report number
1999S1000088
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
Unknown
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000091
UF/Dist Report #
DD
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
patient developed hepatitis at visit 3. study drug discontinued. patient dropped from study.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/12/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
ASHTMA
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 05/01/1999 - 05/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
THEOPHYLLINE 01/01/1999 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
05/14/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Hepatitis NOS
1. Name, address & phone #GALLIEN
2. Health professional?
X yes no
9. Mfr. report number
1999S1000091
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
Unknown
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000092
UF/Dist Report #
KK
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
patient presented with hepatitis at study visit 3. patient hospitalized and dropped from study.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/12/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
ASTHMA
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#1100 MG;QD;PO
3. Therapy dates
#1 05/01/1999 - 05/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
THEOPHYLLINE 01/10/1999 - PRESENT
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
05/12/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Hepatitis NOS
1. Name, address & phone #GALLIEN
2. Health professional?
yes no
9. Mfr. report number
1999S1000092
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
Unknown
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000093
UF/Dist Report #
EE
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
patient enrolled in study of ticlopidine plus saspirin for stroke. Presented with hepatitis at visit 3. Hospitalized and dropped from study. SUspected drug interaction
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/12/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
ASTHMA
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 05/01/1999 - 05/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
THEOPHYLLINE Unknown - Unknown
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
05/14/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Hepatitis NOS
1. Name, address & phone #GALLIEN
2. Health professional?
yes no
9. Mfr. report number
1999S1000093
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
39 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000094
UF/Dist Report #
EE
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient presented at visit 4 with mild neutropenia, fever, chills, malaise. ANC of 950 neutrophils/mm3. Drug discontineud, patient dropped from study, remains under observation.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
05/12/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 04/01/1999 - 05/12/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 STROKE
(indication) 5. Event abated after usestopped or dose reduced
#1 X yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
05/14/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
NeutropeniaBIG TOE SWOLLEN
1. Name, address & phone #BRAD GALLIEN
2. Health professional?
X yes no
9. Mfr. report number
1999S1000094
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
39 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000095
UF/Dist Report #
BB
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1960 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient presented at visit 4 with mild neutropenia, thrombocytopenia, mild anemia, and general weakness. ANC of 7000 neutrophils/mm3. Drug discontineud, patient dropped from study, remains under observation.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
06/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 05/01/1999 - 06/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
06/02/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
NeutropeniaThrombocytopeniaWeaknessAnaemia NOS
1. Name, address & phone #DR BRAD GALLIEN
2. Health professional?
X yes no
9. Mfr. report number
1999S1000095
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
Unknown
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000097
UF/Dist Report #
ABC
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1901 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient presented at visit 4 with 106 degree fever. Hospitalized, lab analysis revealed severe neutropenia ANC of 400 n/mm3. Patient died august 16th, apparently from a viral infection.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
X death(mo/day/yr)
08/17/1999
life-threatening
hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
08/17/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
Unknown
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 08/01/1999 - 08/17/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
08/17/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
HOSPITALIZED FOR FEVERNeutropenia
1. Name, address & phone #SMITH
2. Health professional?
yes no
9. Mfr. report number
1999S1000097
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
98 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000098
UF/Dist Report #
WSE
3. Sex
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
01/01/1901 XFemale
Male
or
lbs
kgs
UNK
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Patient presented at visit 4 with high fever and tiredness, hospitalized. Lab analysis revealed ANC of 750 neutrophils/mm3. Drug discontineud, patient dropped from study, remains under observation.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
08/01/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
None
None
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#150 MG;BID;PO
3. Therapy dates
#1 07/01/1999 - 08/01/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
N/A- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
X health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
08/17/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
HOSPITALIZED FOR FEVERNeutropeniaFatigue
1. Name, address & phone #MD A SMITH
2. Health professional?
X yes no
9. Mfr. report number
1999S1000098
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)
1. Patient Identifier
65 YR
2. Age at time of event:
FDA Facsimile Approval 06/23/98(NetForce)
DRAFT FDA Use Only
Mfr report # 1999S1000135
UF/Dist Report #
ITQQ
3. Sex
X
MED ATCHWTHE FDA MEDICAL PRODUCTS REPORTING PROGRAM
Page 1 of 1
"+" indicatesitem continued
In confidence
4. Weight
Date of birth:
or
05/05/1934Female
Male
or
lbs
kgs
140
A. Patient information
B. Adverse event or product problem
FDA3500A Facsimile
Submission of a report does not constitute an admissionthat medical personnel, user facility, distributor, manufa-cturer or product caused or contributed to the event.
C. Suspect Medication(s)
G. All manufacturers
E. Initial reporter
Dispensing Pharmacist reported a product return of discolored Saspirin tablets. No associated adverse event.
1. X Adverse event and/or Product problem (e.g. defects/malfunctions)
2. Outcomes attributed to adverse event (Check all that apply)
death(mo/day/yr)
life-threatening
X hospitalization - initial or prolonged other:
congenital anomaly
disability
required intervention to preventpermanent impairment/damage
3. Date of event
(mo/day/yr)
11/11/1999 4. Date ofthis report
(mo/day/yr)
10/16/2002
5. Describe event or problem
6. Relevant tests/laboratory data, including dates
7. Other relevant history, including preexisting medical conditions(e.g. allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
TEST NAME DATE RESULT UNITANC 11NOV1999 200 N/MM3
Unknown
(give labeled strength & mfr/labeler, if known)1. Name
#1SASPIRIN
2. Dose, frequency and route used
#125 MG;BID;PO
3. Therapy dates
#1 10/20/1999 - 11/11/1999
(if unknown, give duration)from/to (or best estimate)
4. Diagnosis for use
#1 SECONDARY STROKE
(indication) 5. Event abated after usestopped or dose reduced
#1 yes nodoesn'tapply
yes nodoesn'tapply6. Lot #
#1 Unknown
7. Exp. Date
#1 Unknown
(if known)
8. Event reappeared afterreintroduction
#1 yes nodoesn'tapply
yes nodoesn'tapply
9. NDC #
4778-9401-77- for product problems only (if known)
10. Concomitant medical products and therapy dates (exclude treatment of event)
TICLOPIDINE 06/10/1999 - 09/10/1999
1. Contact office - name/address
NetForce, Inc.345 California StreetSan Francisco, CA 94104U.S.A.
(& mfring site for devices) 2. Phone Number
415-954-7000
3. Report source (check all that apply)
foreign
X study
literature
consumer
health professional
user facility
companyrepresentativedistributor
other:
4.Date received by manufacturer (mo/day/yr)
11/14/1999
5.
(A)NDA #
IND #
PLA #
yes
yes
pre-1938OTCproduct
6. If IND, protocol #
N/A
7. Type of report (check all that apply)
5-day X 15-day
10-day periodic
X initial follow-up #
8. Adverse event term(s)
Headache NOSMiosisInfluenza
1. Name, address & phone #NECROSIS
2. Health professional?
yes no
9. Mfr. report number
1999S1000135
3. Occupation
Unknown
4. Initial reporter alsosent report to FDA
yes no X unk
(if known)