MAUDE report

MAUDE report 35593: KENDALL-CURITY FOLEY CATHETER TRAY

Malfunction · received Jul 9, 1996 · KENDALL HEALTHCARE PRODUCTS CO.

Key facts

MDR report key 35593
Report number 35593
Event type Malfunction
Brand name KENDALL-CURITY FOLEY CATHETER TRAY
Model number 16FR-5CC ULTRAMER
Catalog number 6155
Manufacturer KENDALL HEALTHCARE PRODUCTS CO.
Product code KOD
Device class Class II
Date received by FDA Jul 9, 1996
Report date May 9, 1996
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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