MAUDE report

MAUDE report 3911: PEDIATRIC FOLEY CATH, 8FC

Injury · received Jul 1, 1992 · SHERWOOD MEDICAL/ARGYLE

Key facts

MDR report key 3911
Report number 3911
Event type Injury
Brand name PEDIATRIC FOLEY CATH, 8FC
Model number 500477
Manufacturer SHERWOOD MEDICAL/ARGYLE
Product code KOD
Device class Class II
Date received by FDA Jul 1, 1992
Report date Jun 24, 1992
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
  • 1–9 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