MAUDE report

MAUDE report 11219: BASIC FOLEY CATHETERIZATION TRAY W/O CATHETER W/10 CC SYRING

No Answer Provided · received Feb 2, 1994 · BAXTER HEALTHCARE CORP.

Key facts

MDR report key 11219
Report number MW1000591
Event type No Answer Provided
Brand name BASIC FOLEY CATHETERIZATION TRAY W/O CATHETER W/10 CC SYRING
Catalog number 3T51786
Manufacturer BAXTER HEALTHCARE CORP.
Product code FCM
Device class Class II
Date received by FDA Feb 2, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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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