MAUDE report

MAUDE report 35949: DRILL BIT

Injury · received Aug 13, 1996 · RADIONICS

Key facts

MDR report key 35949
Report number 35949
Event type Injury
Brand name DRILL BIT
Model number DA 2.7
Catalog number *
Manufacturer RADIONICS
Product code HTW
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Aug 13, 1996
Report date Aug 13, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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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