MAUDE report

MAUDE report 8741: OSTIUM PUNCH BACKWARD BITING

Injury · received Mar 18, 1994 · R. WOLF, GMBH

Key facts

MDR report key 8741
Report number 1418479-1994-09013
Event type Injury
Brand name OSTIUM PUNCH BACKWARD BITING
Model number 8211.08
Catalog number 8211.08
Manufacturer R. WOLF, GMBH
Product code KAY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Mar 18, 1994
Report date Feb 22, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 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
  • 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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