BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD GOLD

    MDR report key: 146268 · Received January 20, 1998

    Report

    Report Number
    MW1012876
    Event Type
    Malfunction
    Date Received
    January 20, 1998
    Date of Event
    January 19, 1998
    Report Date
    January 19, 1998
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIOVASCULAR SURGEON USING VASCULAR GRAFT DURING SURGERY. LEAKING NOTED AT BIFURCATION. SURGEON OVERSEWED AREA OF LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD GOLD Implant KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT DSY MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. * 277072

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR