MAUDE report

MAUDE report 60969: THERA DR-I

Injury · received Jan 3, 1997 · MEDTRONIC MED REL, INC.

Key facts

MDR report key 60969
Report number 2647346-1996-00026
Event type Injury
Brand name THERA DR-I
Model number 7960IU
Catalog number *
Manufacturer MEDTRONIC MED REL, INC.
Product code DXY
Device class Class III
Date received by FDA Jan 3, 1997
Report date Dec 30, 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
  • No 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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