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U.S. Department of Health and Human Services

Medical Devices

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Adverse Event Reports - Adverse event reports are Medical Device Reports (MDR) submitted to FDA as deaths, serious injuries, and malfunctions.

Malfunction - The failure of a device to meet its performance specifications or otherwise perform as intended. A malfunction is reportable: when it is likely to cause or contribute to a death or serious injury if it were to recur.

MDR - Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.

Serious Injury - Life-threatening injury or illness results in permanent impairment/ damage to body function/ structure. It requires medical or surgical intervention to preclude permanent impairment/ damage to body function/ structure.

Surgical Stapler - A fastening device made of metal used to close operative wounds.

User Facility - User facilities are hospitals, ambulatory surgical centers, nursing homes, outpatient diagnostic facilities, outpatient treatment facilities.