MAUDE report

MAUDE report 37794: HANCOCK II MITRAL HEART VALVE

Injury · received Aug 30, 1996 · MEDTRONIC HEART VALVE DIV.

Key facts

MDR report key 37794
Report number 2025587-1996-00001
Event type Injury
Brand name HANCOCK II MITRAL HEART VALVE
Model number T510
Catalog number T51029H
Manufacturer MEDTRONIC HEART VALVE DIV.
Product code LWQ
Device class Class III
Date received by FDA Aug 30, 1996
Report date Aug 27, 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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