Mandatory Form
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1
2Form Approved: OMB No. 0910-0291 Expires: 8/31/00
See OMB statement on reverse
For use by user-facilities,
Mfr report #
distributors and manufacturers for
MANDATORY
reporting
UF/Dist report #
Page
____ of ____
FDA Use Only
C. Suspect medication(s)
A. Patient information
2. Age at time
1. Patient identifier
3. Sex
4. Weight
1. Name (give labeled strength & mfr/labeler, if known)
of event:
#1
lbs
female
or
or
Date
male
#2
of birth:
kgs
In confidence
3. Therapy dates (if unknown, give duration)
2. Dose, frequency & route used
B. Adverse event or product problem
from/to (or best estimate)
#1
#1
1.
Adverse event
and/or
Product problem (e.g., defects/malfunctions)
2. Outcomes attributed to adverse event
#2
#2
disability
(check all that apply)
4. Diagnosis for use (indication)
5. Event abated after use
congenital anomaly
death __________________
stopped or dose reduced
#1
(mo/day/yr)
required intervention to prevent
life-threatening
doesn't
#1
permanent impairment/damage
yes
no
apply
#2
hospitalization – initial or prolonged
other:
doesn't
___________________
yes
no
#2
apply
6. Lot # (if known)
7. Exp. date (if known)
3. Date of
4. Date of
#1
#1
8. Event reappeared after
event
this report
(mo/day/yr)
(mo/day/yr)
reintroduction
#2
#2
5. Describe event or problem
doesn't
#1
yes
no
apply
9. NDC # – for product problems only (if known)
doesn't
yes
no
–
–
#2
apply
10. Concomitant medical products and therapy dates (exclude treatment of event)
D. Suspect medical device
1. Brand name
2. Type of device
4. Operator of device
3. Manufacturer name & address
health professional
lay user/patient
other:
________________
5. Expiration date
6.
(mo/day/yr)
model #________________________________________
7. If implanted, give date
catalog #_______________________________________
6. Relevant tests/laboratory data, including dates
(mo/day/yr)
serial # ________________________________________
8. If explanted, give date
lot # ___________________________________________
(mo/day/yr)
other #
9. Device available for evaluation?
(Do not send to FDA)
yes
no
returned to manufacturer on _________________
(mo/day/yr)
10. Concomitant medical products and therapy dates (exclude treatment of event)
7. Other relevant history, including preexisting medical conditions (e.g., allergies,
race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
E. Initial reporter
1.
Name & address
phone #
4
Initial reporter also
2. Health professional?
3.
Occupation
Submission of a report does not constitute an
sent report to FDA
admission that medical personnel, user facility,
yes
no
yes
no
unk
distributor, manufacturer or product caused or
contributed to the event.
FDA Form 3500A
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