BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD KNITTED DOUBLE VELOUR FABRIC

    MDR report key: 99343 · Received June 19, 1997

    Report

    Report Number
    2242352-1997-00049
    Event Type
    Malfunction
    Date Received
    June 19, 1997
    Date of Event
    May 22, 1997
    Report Date
    May 23, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATCH LEAKED AN UNKNOWN QUANTITY OF BLOOD FROM ITS SURFACE AND SUTURE HOLES WHEN THE CLAMP WAS RELEASED. GELFOAM WAS APPLIED TO THE PATCH AND CLOTTING EVENTUALLY OCCURRED. THE PATCH WAS LEFT IN. THE PT'S CONDITION IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant CARDIOVASCULAR FABRIC DXZ MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 019508 526159

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other