BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 48108 · Received November 6, 1996

    Report

    Report Number
    2242352-1996-00036
    Event Type
    Malfunction
    Date Received
    November 6, 1996
    Date of Event
    October 7, 1996
    Report Date
    October 11, 1996
    Manufacturer
    MEADOX MEDICALS, INC. DIV BSC
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE GRAFT LEAKED BLOOD (QUANTITY UNKNOWN, BUT REPORTED AS INSIGNIFICANT) THROUGH A HOLE IN THE CROTCH. THE DR OVERSEWED THE HOLE AND THE BLEEDING STOPPED. THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCUALAR GRAFT MAL MEADOX MEDICALS, INC. DIV BSC 085189 456059

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other