MAUDE report

MAUDE report 43121: HEMASHIELD MICROVEL DOULBE VELOUR GRAFT

Malfunction · received Oct 16, 1996 · BOSTON SCIENTIFIC CORPORATION

Key facts

MDR report key 43121
Report number 2242352-1996-00034
Event type Malfunction
Brand name HEMASHIELD MICROVEL DOULBE VELOUR GRAFT
Model number 095218
Catalog number 095218
Manufacturer BOSTON SCIENTIFIC CORPORATION
Product code MAL
Device class Class II
Date received by FDA Oct 16, 1996
Report date Sep 30, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None 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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