BEUDAMED
    FDA Adverse Event Other Summary report: N

    REM POLYHESIVE II

    MDR report key: 211839 · Received February 25, 1999

    Report

    Report Number
    MW1015790
    Event Type
    Other
    Date Received
    February 25, 1999
    Date of Event
    February 14, 1999
    Report Date
    February 16, 1999
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BRUISE NOTED AROUND EDGE WHERE CAUTERY PAD WAS PLACED ON PT. NOTED UPON REMOVAL OF PAD FOLLOWING C-SECTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REM POLYHESIVE II DISPOSABLE PATIENT RETURN ELECTRODE W/CORD GEI VALLEYLAB, INC. UNK 36965

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other