MAUDE report

MAUDE report 43674: DARDIK BIOGRAFT

Injury · received Oct 18, 1996 · BIO-VASCULAR

Key facts

MDR report key 43674
Report number 2183620-1996-00004
Event type Injury
Brand name DARDIK BIOGRAFT
Model number 405506
Catalog number 405506
Manufacturer BIO-VASCULAR
Product code DSY
Device class Class II
Date received by FDA Oct 18, 1996
Report date Oct 13, 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
  • 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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