MAUDE report

MAUDE report 8976: AMFAMP

Injury · received Aug 11, 1993 · LUMEX VERSARAIL

Key facts

MDR report key 8976
Report number 8976
Event type Injury
Brand name AMFAMP
Model number 5074
Manufacturer LUMEX VERSARAIL
Date received by FDA Aug 11, 1993
Report date Mar 30, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports