BEUDAMED
    FDA Adverse Event Other Summary report: N

    REM POLY HESIVE II

    MDR report key: 209780 · Received February 10, 1999

    Report

    Report Number
    MW1015674
    Event Type
    Other
    Date Received
    February 10, 1999
    Date of Event
    February 5, 1999
    Report Date
    February 8, 1999
    Manufacturer
    VALLEY LAB, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING CESAREAN-SECTION WHEN CAUTERY WAS REMOVED, AN AREA OF BRUISING WAS NOTED WHICH WAS THE SAME OUTLINE AS THE OUTSIDE EDGE OF THE CAUTERY PAD WHICH HAS ADHESIVE ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REM POLY HESIVE II DISPOSABLE PATIENT RETURN ELECTRODE WITH CORD GEI VALLEY LAB, INC. NA 36769

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other