MAUDE report

MAUDE report 68468: BAXTER

Malfunction · received Feb 13, 1997 · BAXTER HEALTHCARE CORP. SURGICAL GROUP

Key facts

MDR report key 68468
Report number MW1010709
Event type Malfunction
Brand name BAXTER
Model number *
Catalog number PS 616
Manufacturer BAXTER HEALTHCARE CORP. SURGICAL GROUP
Product code KOD
Device class Class II
Date received by FDA Feb 13, 1997
Report date Feb 4, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 100–999 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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