MAUDE report

MAUDE report 3907: UNKNOWN

Death · received Jul 8, 1992 · PCP CHAMPION DIVISION OF SURGICAL APPL. IND., INC.

Key facts

MDR report key 3907
Report number 3907
Event type Death
Brand name UNKNOWN
Model number 6083
Manufacturer PCP CHAMPION DIVISION OF SURGICAL APPL. IND., INC.
Product code FNK
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jul 8, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this product code
  • 1,000+ MAUDE reports for this brand
  • 100–999 Death reports for this brand
  • 1,000+ 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