MAUDE report

MAUDE report 71073: HEART MATE

Injury · received Feb 20, 1997 · THERMOCARDIO SYSTEMS

Key facts

MDR report key 71073
Report number 71073
Event type Injury
Brand name HEART MATE
Model number UNK
Catalog number UNK
Manufacturer THERMOCARDIO SYSTEMS
Product code DSQ
Device class Class III
Date received by FDA Feb 20, 1997
Report date Feb 12, 1997
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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