Within 14 calendar days, UM and/or the HDE holder must submit to both the FDA and the IRBMED a Medical Device Report (MDR), informing them of one or both of the following events:
- The HUD appears to have caused or contributed to death or serious injury.
- The HUD appears to have malfunctioned and is likely to cause or contribute to death or serious injury should the malfunction recur.
FDA defines a serious injury as one that:
- is life-threatening;
- results in permanent impairment of a body function;
- results in permanent damage to a body structure;
- necessitates medical or surgical intervention to preclude permanent impairment of a body function; or
- necessitates medical or surgical intervention to preclude permanent damage to a body structure.
When reporting the event, use the eResearch UM Serious Adverse Event form. As Section 32 of the eResearch application is not triggered for the HUD applications, the above outlined AE reporting plan should be followed.