MAUDE report

MAUDE report 51296: HANCOCK STANDARD MITRAL HEART VALVE

Injury · received Nov 22, 1996 · MEDTRONIC HEART VALVES, INC.

Key facts

MDR report key 51296
Report number 2025587-1996-00027
Event type Injury
Brand name HANCOCK STANDARD MITRAL HEART VALVE
Model number 342
Catalog number HM342R31H
Manufacturer MEDTRONIC HEART VALVES, INC.
Product code LWR
Device class Class III
Date received by FDA Nov 22, 1996
Report date Oct 25, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 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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