MAUDE report

MAUDE report 40799: TEFLON COATED LATEX FOLEY CATHETER

Malfunction · received Oct 4, 1996 · SHERWOOD DAVIS AND GECK

Key facts

MDR report key 40799
Report number 9610849-1996-00003
Event type Malfunction
Brand name TEFLON COATED LATEX FOLEY CATHETER
Catalog number 8887-621665
Manufacturer SHERWOOD DAVIS AND GECK
Product code FCN
Device class Class II
Date received by FDA Oct 4, 1996
Report date Sep 5, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • 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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