BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUS GRAFT

    MDR report key: 83050 · Received April 7, 1997

    Report

    Report Number
    2242352-1997-00032
    Event Type
    Malfunction
    Date Received
    April 7, 1997
    Date of Event
    March 11, 1997
    Report Date
    March 11, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED AS AN AORTO-BIFEMORAL BYPASS GRAFT. AFTER IMPLANTATION, THE GRAFT LEAKED BLOOD FROM THE AREA OF THE BIFURCATION (CROTCH). THE QUANITY OF BLOOD THAT LEAKED THROUGH THE GRAFT IS UNKNOWN. THE GRAFT WAS REPAIRED WITH A SUTURE AND THEN BECAME BLOOD-TIGHT. 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 VELOUS GRAFT Implant SEALED MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 085189 366319

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other