The FDA has designed a medical reporting program called MedWatch. This system encourages health care professionals to consider reporting adverse events and product problems as a fundamental health care responsibility. All health care professionals are expected to report adverse events, even if they are uncertain that the product caused the event and even though they do not have all the details. Hospitals are required to use the FDA Form 3500A for reporting product problems associated with medical devices. Personnel are to fill out the MCL Form #740 incident report and the FDA Form 3500A for reporting Medical Device malfunctions will be compiled by the Risk Management Department.



MedWatch website

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