Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 3
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18MedWatch - Instructions for MedWatch Form 3500
3 of 18
Identify all attached pages as Page __ of __
Indicate the appropriate section and block number next to the narrative continuation
Include the phrase continued at the end of each field that has additional information
continued onto another page
If the case report involves more than two (2) suspect products, please submit another
copy of FDA Form 3500, with only section D or section E filled in as appropriate.
Section D, Suspect product[s], should be used to report on special nutritional
products and cosmetics as well as drugs or biologics, including human cells, tissues,
and cellular and tissue-based products (HCT/Ps).
If your report involves a serious adverse event with a device and it occurred in a
facility other than a doctor's office, that facility may be legally required to report to
FDA and/or the manufacturer. Please notify the person in that facility who would
handle such reporting.
QUESTIONS ABOUT VOLUNTARY REPORTING?
Call MedWatch at
1-800-FDA-1088
(1-800-332-1088)
INDEX
To read instructions for a specific section, click a link from the list below.
SECTION A:
PATIENT INFORMATION
A1:
Patient Identifier
A2:
Age at Time of Event or Date of Birth
A3:
Sex
A4:
Weight
SECTION
B: ADVERSE EVENT, PRODUCT PROBLEM OR ERROR
B1:
Adverse Event, Product Problem, Product Use Error or Problem with
Different Manufacturer of Same Medicine
B2:
Outcomes Attributed to Adverse Event
B3:
Date of Event
B4:
Date of this Report
B5:
Describe Event, Problem or Product Use Error
B6:
Relevant Tests/Laboratory Data, Including Dates
B7:
Other Relevant History, Including Preexisting Medical Conditions
SECTION C:
PRODUCT AVAILABILITY
C1:
Product Available for Evaluation?
SECTION D:
SUSPECT PRODUCT(S)
D1:
Name, Strength, Manufacturer
D2:
Dose or Amount, Frequency, Route
8/8/2006 1:41 PM
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