MAUDE report

MAUDE report 21498: SWAN-GANZ PACEPORT CATHETER WITH AMC THROMBOLOID

Malfunction · received Apr 26, 1995 · BAXTER HEALTHCARE CORP.

Key facts

MDR report key 21498
Report number MW1005740
Event type Malfunction
Brand name SWAN-GANZ PACEPORT CATHETER WITH AMC THROMBOLOID
Model number 93A-931H 7.5 F
Manufacturer BAXTER HEALTHCARE CORP.
Product code DYG
Device class Class II
Date received by FDA Apr 26, 1995
Report date Mar 30, 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
  • 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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