MAUDE report

MAUDE report 42316: SILICONE FOLEY CATHETER

Injury · received Oct 11, 1996 · SHERWOOD DAVIS AND GECK

Key facts

MDR report key 42316
Report number 9610849-1996-00006
Event type Injury
Brand name SILICONE FOLEY CATHETER
Catalog number 8887-665227
Manufacturer SHERWOOD DAVIS AND GECK
Product code KOD
Device class Class II
Date received by FDA Oct 11, 1996
Report date Sep 12, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes 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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