MAUDE report

MAUDE report 1724: CARPENTER EDWARDS BIOPROSTHESIS #35

Death · received Oct 22, 1992 · AMERICAN EDWARDS LABORATORIES

Key facts

MDR report key 1724
Report number 1724
Event type Death
Brand name CARPENTER EDWARDS BIOPROSTHESIS #35
Model number 6625
Catalog number UNKNOWN
Manufacturer AMERICAN EDWARDS LABORATORIES
Product code DYE
Device class Class III
Date received by FDA Oct 22, 1992
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
  • None 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:

Browse all MAUDE medical device reports