BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 533806 · Received March 12, 2004

    Report

    Report Number
    6000072-2004-00013
    Event Type
    Malfunction
    Date Received
    March 12, 2004
    Date of Event
    February 12, 2004
    Report Date
    February 13, 2004
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR CLAIMS THAT THE GRAFT WAS IMPLANTED FOR AN AORTO-BIFEMORAL PROCEDURE AND LEAKED BLOOD AT THE BIFURCATION. THE LEAKAGE WAS STOPPED BY SEWING IN A PLEDGET. THE GRAFT WAS LEFT IN. THE PROCEDURE OUTCOME WAS FINE. THE PT'S CONDITION WAS FINE. NOTE: IN 2/2003 MFR RECEIVED THE FOLLOWING ADD'L INFO: THE TYPE OF LEAKAGE WAS REPORTED AS AN "OOZE" AND WITH MINIMAL BLOOD LOSS. THE BATCH NUMBER, INITIALLY NOT REPORTED HAS NOW BEEN REPORTED AS 5884419.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT MAL BOSTON SCIENTIFIC WAYNE 085127 5884419

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other