GLOSSARY

MedWatch Form

“A MedWatch Form is used to report an adverse or sentinel event to MedWatch” - the United States Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program.

Founded in 1993, the MedWatch program was established by the FDA to help collect data on adverse events in the healthcare industry. Adverse events range in severity between mild and lethal, but the term is generally used to describe any event that is undesirable in connection with the use of a specific medical device or product.

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.

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What Information Goes on a MedWatch Form / Form FDA 3500A?

The current MedWatch form asks the reporter of an adverse event to fill out several different categories of information before making a submission. There are additional fields that can be filled out when the adverse event is reported by a manufacturer or a user facility/importer. The FDA expects to receive the following information in every MedWatch adverse event report submitted:

Section A: Patient Information - The reporter is requested to include identifying information for the patient that will be submitted in confidence, including the patient's age, ethnicity/race, sex and weight.

Section B: Adverse Event or Product Problem - The reporter should indicate whether the report pertains to an adverse event or a problem with the product, and what outcome was attributed to the adverse event (if applicable). The date of the event, date of the report, and a description of the event along with other relevant patient history are all requested as part of this section.

Section C: Suspect Product(s) - The reporter should list all medical products that are suspected to have contributed to the adverse event.

Section D: Suspect Medical Device - The reporter should provide details about the medical device that is suspected to have contributed to the adverse event, including the brand name, device name, manufacturer name and other identifying information from the label (UDI, Serial #, etc.).

Section E: Initial Reporter - Medwatch Forms submitted to the FDA should contain information that would allow the FDA to follow up with the original event reporter if any additional questions arise. The reporter is expected to provide their full name and address, phone number, and contact email.

Section F: For Use By User Facility/Importer - If a user facility or importer fills out the MedWatch form, they should fill out this section to offer additional details such as the importer name/address, contact person, and whether a report of the adverse event was sent on to the manufacturer. User facilities are subject to mandated reporting of adverse events within a certain time frame, and the dating on these forms should reflect that the user facility did its due diligence in producing a timely report of the event, as well as notifying the manufacturer.

Section G: All Manufacturers - If the reporter is a manufacturer, it must include specific details about the product, detail how it learned about the adverse event, and establish what type of report is being made (15-day, 10-day, 30-day, etc.).

Section H: Device Manufacturers Only - This section requires device manufacturers to fill in more specific details, including the type of reportable event that occurred, how follow-up was conducted, whether the manufacturer has evaluated the device in question, when the device was manufactured and whether the device was properly labeled for single use. The manufacturer should also indicate what remedial actions were taken.

In addition to the FDA Form 3500A, an additional Medwatch Form exists known as Form FDA 3500B. This form was designed to be more consumer-friendly.

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Post-market surveillance is a growing focus in the world of medical device quality, and that includes the mandatory adverse event reporting requirements that the FDA places on medical device companies. Medical device companies must submit the appropriate MedWatch forms in a timely manner when they become aware that an adverse event has occurred, with failure to comply potentially leading to fines or other legal action.

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