MAUDE report

MAUDE report 22962: PEDIATRIC SILICONE FOLEY 6F

Injury · received May 24, 1995 · PORGES S.A. CENTRE D'AFFAIRES LA BOURSIDIERE

Key facts

MDR report key 22962
Report number 2429473-1995-00014
Event type Injury
Brand name PEDIATRIC SILICONE FOLEY 6F
Catalog number AA6106
Manufacturer PORGES S.A. CENTRE D'AFFAIRES LA BOURSIDIERE
Product code KOD
Device class Class II
Date received by FDA May 24, 1995
Report date May 23, 1995
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:

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