Form Fda 3500 - The Fda Safety Information And Adverse Event Reporting Program

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U.S. Department of Health and Human Services
Form Approved: OMB No. 0910-0291, Expires: 10/31/08
See OMB statement on reverse.
For VOLUNTARY reporting of
M
W
ED
ATCH
FDA USE ONLY
adverse events, product problems and
Triage unit
product use errors
sequence #
The FDA Safety Information and
Page ____ of ____
Adverse Event Reporting Program
A. PATIENT INFORMATION
D. SUSPECT PRODUCT(S)
1. Patient Identifier
2. Age at Time of Event, or
3. Sex
4. Weight
1. Name, Strength, Manufacturer (from product label)
Date of Birth:
lb
Female
#1
or
Male
kg
In confidence
#2
B. ADVERSE EVENT, PRODUCT PROBLEM OR ERROR
2.
Dose or Amount
Frequency
Route
Check all that apply:
#1
1.
Adverse Event
Product Problem (e.g., defects/malfunctions)
Product Use Error
Problem with Different Manufacturer of Same Medicine
#2
2. Outcomes Attributed to Adverse Event
(Check all that apply)
3. Dates of Use (If unknown, give duration) from/to (or
5. Event Abated After Use
best estimate)
Stopped or Dose Reduced?
Death:
Disability or Permanent Damage
Doesn't
(mm/dd/yyyy)
#1
Yes
No
#1
Apply
Life-threatening
Congenital Anomaly/Birth Defect
Doesn't
#2
Other Serious (Important Medical Events)
#2
Yes
No
Hospitalization - initial or prolonged
Apply
4. Diagnosis or Reason for Use (Indication)
Required Intervention to Prevent Permanent Impairment/Damage (Devices)
8. Event Reappeared After
Reintroduction?
#1
3. Date of Event (mm/dd/yyyy)
4. Date of this Report (mm/dd/yyyy)
Doesn't
#1
Yes
No
Apply
#2
Doesn't
5. Describe Event, Problem or Product Use Error
6. Lot #
7. Expiration Date
#2
Yes
No
Apply
#1
#1
9. NDC # or Unique ID
#2
#2
E. SUSPECT MEDICAL DEVICE
1. Brand Name
2. Common Device Name
3. Manufacturer Name, City and State
4. Model #
Lot #
5. Operator of Device
Health Professional
Catalog #
Expiration Date (mm/dd/yyyy)
Lay User/Patient
Other:
Serial #
Other #
6. If Implanted, Give Date (mm/dd/yyyy)
7. If Explanted, Give Date (mm/dd/yyyy)
8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?
Yes
No
9. If Yes to Item No. 8, Enter Name and Address of Reprocessor
6. Relevant Tests/Laboratory Data, Including Dates
F. OTHER (CONCOMITANT) MEDICAL PRODUCTS
Product names and therapy dates (exclude treatment of event)
7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies,
race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.)
G. REPORTER (See confidentiality section on back)
1. Name and Address
Phone #
E-mail
2. Health Professional?
3. Occupation
4. Also Reported to:
C. PRODUCT AVAILABILITY
Yes
No
Manufacturer
Product Available for Evaluation? (Do not send product to FDA)
User Facility
5. If you do NOT want your identity disclosed
Yes
No
Returned to Manufacturer on:
Distributor/Importer
to the manufacturer, place an "X" in this box:
(mm/dd/yyyy)
FORM FDA 3500 (10/05)
Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.

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