MAUDE report

MAUDE report 78105: BEAR

Injury · received Feb 27, 1997 · BEAR MED. SYSTEMS

Key facts

MDR report key 78105
Report number 78105
Event type Injury
Brand name BEAR
Model number 13530
Catalog number NI
Manufacturer BEAR MED. SYSTEMS
Product code CBK
Device class Class II
Date received by FDA Feb 27, 1997
Report date Sep 26, 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
  • 10–99 Death reports for this brand
  • 100–999 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:

Browse all MAUDE medical device reports