MAUDE report

MAUDE report 35461: SWANZ GANZ TD CATHETER

No Answer Provided · received Jun 28, 1996 · BAXTER EDWARDS HEALTHCARE DIVISION

Key facts

MDR report key 35461
Report number 35461
Event type No Answer Provided
Brand name SWANZ GANZ TD CATHETER
Manufacturer BAXTER EDWARDS HEALTHCARE DIVISION
Product code DYG
Device class Class II
Date received by FDA Jun 28, 1996
Report date Mar 14, 1996
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:

Browse all MAUDE medical device reports