How do I complete and submit an individual adverse event report?
(a) What form must I complete and submit? There are two versions of the MEDWATCH form for individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form 3500 to submit voluntary reports regarding FDA-regulated products. If you are a user facility, importer, or manufacturer, you must use the FDA Form 3500A to submit mandatory reports about FDA-regulated products. (1) If you are a user facility, importer, or manufacturer, you must complete the applicable blocks on the front of FDA Form 3500A. The front of the form is used to submit information about the patient, the event, the device, and the “initial reporter” (i.e., the first person or entity who reported the information to you). (2) If you are a user facility, importer, or manufacturer, you must complete the applicable blocks on the back of the form. If you are a user facility or importer, you must complete block F. If you are a manufacturer, you must complete blocks G and H. If you are a
