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Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.
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.
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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Please provide the name, mailing address, phone number, and email address of the person who initially reported the adverse event to the user facility, manufacturer, or importer, and who can be contacted to provide information on the event if follow-up is necessary.
Manufacturers must submit a five-day report on form FDA 3500A within five days under the following two conditions: They become aware that an MDR reportable event, from any source, requires remedial action to prevent an unreasonable risk of substantial harm to the public health.
Form FDA 3500A is used for mandatory reporting (i.e., required by law or regulation), primarily by regulated industry reporters but also for certain User Facility reporters for reports related to deaths associated with medical devices.

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