BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD KNITTED DOUBLE VELOUR FABRIC

    MDR report key: 57478 · Received December 17, 1996

    Report

    Report Number
    2242352-1996-00075
    Event Type
    Malfunction
    Date Received
    December 17, 1996
    Date of Event
    November 11, 1996
    Report Date
    November 19, 1996
    Manufacturer
    MEADOX MEDICALS, INC, DIV BSC
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FABRIC WAS IMPLANTED FOR A CAROTID ENDARTERECTOMY PROCEDURE. WHEN THE VESSEL WAS DECLAMPED, THE PATCH LEAKED BLOOD (QUANTITY UNKNOWN). THE BLEEDING WAS STOPPED BY PATCHING THE PATCH. THE PATCH WAS LEFT IN. THE PT'S CONDITION IS FINE - NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant CARDIOVASCULAR FABRIC DXZ MEADOX MEDICALS, INC, DIV BSC 019508 446159

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other