BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 82854 · Received April 7, 1997

    Report

    Report Number
    2242352-1997-00028
    Event Type
    Malfunction
    Date Received
    April 7, 1997
    Date of Event
    February 12, 1997
    Report Date
    March 11, 1997
    Manufacturer
    MEADOX MEDICALS, INC. DIV BSC
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER IMPLANTING, THE GRAFT "OOZED SLIGHTLY" FROM THE AREA OF THE BIFURCATION. THE QUANTITY OF BLOOD LOST THROUGHT THE GRAFT IS NOT ATTAINABLE. THE OOZING WAS RAPIDLY STOPPED WITH A HEMOSTATIC COMPRESS AND THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS FINE. THE PT WAS DISCHARGED TWELVE DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, INC. DIV BSC 085147 326312

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other