MAUDE report

MAUDE report 3068: DURAPHASE PROSTHESIS DURAPHASE BODIES, DISTAL TIPS, PROXIMAL

Injury · received Jul 27, 1992 · DACOMED

Key facts

MDR report key 3068
Report number 3068
Event type Injury
Brand name DURAPHASE PROSTHESIS DURAPHASE BODIES, DISTAL TIPS, PROXIMAL
Model number 800120-010/800213-001/800213/4
Catalog number UNKNOWN
Manufacturer DACOMED
Product code FAE
Device class Class II
Date received by FDA Jul 27, 1992
Report date Jun 22, 1992
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
  • 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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