MAUDE report

MAUDE report 512

Injury · received Apr 23, 1992 · SURGITEK

Key facts

MDR report key 512
Report number 512
Event type Injury
Model number UNKNOWN
Catalog number UNKNOWN
Manufacturer SURGITEK
Product code FTR
Device class Class III
Date received by FDA Apr 23, 1992
Report date Apr 9, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 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:

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