BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 48119 · Received November 6, 1996

    Report

    Report Number
    2242352-1996-00035
    Event Type
    Malfunction
    Date Received
    November 6, 1996
    Date of Event
    October 9, 1906
    Report Date
    October 9, 1996
    Manufacturer
    MEADOX MEDICALS, INC., DIV. BSC
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PORTION OF THE GRAFT ACTUALLY INVOLVED IN THE INCIDENT WAS LEFT IN THE PT, AND SO COULD NOT BE RETURNED FOR EVAL. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED OR DENIED. A RETURNED, UNUSED SEGMENT OF THIS GRAFT WAS EVALUATED BO CO'S CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. CODE 86: THE MANUFACTURING BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL-NO SIMILAR COMPLAINTS AGAINST THIS BATCH.

    Description of Event or Problem · 1

    WHEN THE PROXIMAL CLAMP WAS RELEASED, THE GRAFT OOZED BLOOD (QUANTITY UNKNOWN) FROM ITS WALLS. THE BLEEDING STOPPED BY ITSELF AFTER A SHORT TIME 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 085127 366141

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other