MAUDE report

MAUDE report 32954: PORCINE AORTIC VALVE

Injury · received Mar 19, 1996 · EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 32954
Report number 32954
Event type Injury
Brand name PORCINE AORTIC VALVE
Model number 2625
Catalog number UNKNOWN
Manufacturer EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.
Product code LWQ
Device class Class III
Date received by FDA Mar 19, 1996
Report date Mar 18, 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
  • 1–9 Injury reports for this brand
  • Yes 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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