MAUDE report

MAUDE report 5641: BARDEX FOLEY CATHETERS & BARD FOLEY TRAY W/ BARDEX LUBRICATH

Malfunction · received Jul 13, 1993 · BARD UROLOGICAL DIVISION (CR BARD, INC.)

Key facts

MDR report key 5641
Report number 5641
Event type Malfunction
Brand name BARDEX FOLEY CATHETERS & BARD FOLEY TRAY W/ BARDEX LUBRICATH
Manufacturer BARD UROLOGICAL DIVISION (CR BARD, INC.)
Product code KOD
Device class Class II
Date received by FDA Jul 13, 1993
Report date Jun 29, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ 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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