MAUDE report

MAUDE report 17614: SWAN GANZ CATHETER

Death · received Oct 7, 1994 · EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 17614
Report number 17614
Event type Death
Brand name SWAN GANZ CATHETER
Model number 746H8F
Manufacturer EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.
Product code DYG
Device class Class II
Date received by FDA Oct 7, 1994
Report date Oct 6, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 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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