MAUDE report

MAUDE report 20591

Malfunction · received Mar 1, 1995 · STRATO MEDICAL CORP.

Key facts

MDR report key 20591
Report number 20591
Event type Malfunction
Manufacturer STRATO MEDICAL CORP.
Date received by FDA Mar 1, 1995
Report date Sep 13, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 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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