MAUDE report

MAUDE report 16153: FOLEY CATHETER, 16 FR

Malfunction · received Sep 15, 1994 · BARD UROLOGICAL DIV. C.R. BARD, INC.

Key facts

MDR report key 16153
Report number MW1003373
Event type Malfunction
Brand name FOLEY CATHETER, 16 FR
Model number 0165L16
Catalog number 899616
Manufacturer BARD UROLOGICAL DIV. C.R. BARD, INC.
Product code KOD
Device class Class II
Date received by FDA Sep 15, 1994
Report date Sep 5, 1994
Report source Maude

At a glance

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