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Click ‘Get Form’ to open the medwatch document in the editor.
Begin by filling out Section A, Patient Information. Enter the patient identifier, age at the time of the event, or date of birth. Ensure accuracy for proper identification.
In Section B, Adverse Event or Product Problem, check the appropriate boxes to indicate whether you are reporting an adverse event and/or a product problem. Provide details about the event in the description field.
Proceed to Section C for Suspect Medication(s). List all medications involved, including their strength and manufacturer. Fill in additional fields such as weight and outcomes attributed to the adverse event.
Complete Section D for Suspect Medical Device if applicable. Include brand name, type of device, and relevant dates. Indicate if the device is available for evaluation.
Finally, fill out Section E for Reporter Information. Provide your name, address, occupation, and whether you are a health professional. If confidentiality is desired, mark the appropriate box.
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MedWatch is the U.S. Food and Drug Administrations (FDA) safety information and adverse event reporting program.
What is the purpose of MedWatch?
MedWatch, the FDAs medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines.
What is MedWatch used for?
The FDA receives the report and conducts an initial review to ensure it includes essential information such as patient details, the suspected product, adverse event description, and contact information. The report is entered into the FDA Adverse Event Reporting System (FAERS) or other relevant databases.
What is a MedWatch form?
The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.
What is a MedWatch?
MEDWATCH is a system that. provides safety alerts for drugs, biologicals, dietary supplements, and medical devices. MedWatch is a voluntary program that allows people to report a serious adverse event associated with the use of any products approved for use by the FDA.
Food and Drug Administration - MedWatch. 10903 New Hampshire Avenue. Building 22, Mail Stop 4447. Silver Spring, MD 20993-0002. G. ALL MANUFACTURERS. 3. User
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