MAUDE report

MAUDE report 23097: PENTALUMEN THERMODILUTION CATHETER

Death · received May 26, 1995 · ABBOTT

Key facts

MDR report key 23097
Report number 23097
Event type Death
Brand name PENTALUMEN THERMODILUTION CATHETER
Manufacturer ABBOTT
Product code DYG
Device class Class II
Date received by FDA May 26, 1995
Report date May 22, 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
  • 1–9 Death reports for this brand
  • 1–9 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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