Medwatch - Instructions For Medwatch Form 3500 - Voluntary Reporting Of Adverse Events Page 16
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18MedWatch - Instructions for MedWatch Form 3500
16 of 18
the reprocessed device.
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SECTION F: OTHER (CONCOMITANT) MEDICAL PRODUCTS
Information on the use of concomitant medical products can frequently provide insight into
previously unknown interactions between products, or provide an alternative explanation for
the observed adverse event. Please list and provide product names and therapy dates for
any other medical products (drugs, biologics including HCT/Ps, medical devices, etc.) that
the patient was using at the time of the event. Do not include products used to treat the
event.
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SECTION G: INITIAL REPORTER
FDA recognizes that confidentiality is an important concern in the context of adverse
event reporting. The patient's identity is held in strict confidence by FDA and
protected to the fullest extent of the law. However, to allow for timely follow-up in
serious cases, the reporter's identity may be shared with the manufacturer unless
specifically requested otherwise in block G5. The FDA will not disclose the reporter’s
identity in response to a request from the public, pursuant to the Freedom of
Information Act.
G1: Name, Address, Phone #, Email
Please provide the name, mailing address, phone number and E-mail address
of the person who can be contacted to provide information on the event if
follow-up is necessary. While optional, providing the fax number would be most
helpful, if available. This person will also receive an acknowledgment letter from
FDA on receipt of the report.
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G2: Health Professional?
Please indicate whether you are a health professional (e.g. physician,
pharmacist, nurse, etc.) or not. If you are not a health professional, please
complete block G3 by filling in NA.
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G3: Occupation:
Please indicate your occupation (particularly type of health professional), and
include specialty, if appropriate.
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G4:
Also Reported to:
8/8/2006 1:41 PM
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