MAUDE report

MAUDE report 49937: CARDIFIX

Death · received Nov 15, 1996

Key facts

MDR report key 49937
Report number 1640319-1996-00540
Event type Death
Brand name CARDIFIX
Model number 438-07
Product code DTB
Device class Class III
Date received by FDA Nov 15, 1996
Report date Nov 15, 1996
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
  • 1–9 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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