BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 57429 · Received December 17, 1996

    Report

    Report Number
    2242352-1996-00074
    Event Type
    Malfunction
    Date Received
    December 17, 1996
    Date of Event
    November 13, 1996
    Report Date
    November 19, 1996
    Manufacturer
    MEADOX MEDICALS, INC, DIV BSC
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED FOR A FEMORO-POPLITEAL GRAFT. AFTER DECLAMPING, THE GRAFT LEAKED BLOOD (QUANTITY UNKNOWN, BUT REPORTED AS INSIGNIFICANT BY DR) FROM ITS WALLS. THE BLEEDING WAS STOPPED WITH HEMOSTATIC AGENTS (NOT IDENTIFIED) AND THE GRAFT WAS LEFT IN. THE PT'S CONDITION IS OK.

    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 095408 224355

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other