MAUDE report

MAUDE report 3714

Malfunction · received Aug 3, 1992 · OM S (OPTICAL MICRO SYSTEMS)

Key facts

MDR report key 3714
Report number 3714
Event type Malfunction
Model number 20-01-02 REV.A
Manufacturer OM S (OPTICAL MICRO SYSTEMS)
Product code HQC
Device class Class II
Date received by FDA Aug 3, 1992
Report date Apr 13, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • No Adverse event flagged
  • Yes 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:

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