BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE GEL PADS

    MDR report key: 2989449 · Received February 28, 2013

    Report

    Report Number
    MW5029191
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    GF HEAL PRODUCTS INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT IS USING REUSABLE ELECTRODE GEL PADS FOR PAIN MANAGEMENT FOR 6-10 HOURS. PATIENT EXPERIENCED, SORENESS, BLISTERING AND OOZING YELLOWISH FLUID FROM HIS BACK FOR 3 WEEKS. PATIENT IS TAKING ANTIBIOTICS AND USING BETADINE TO CLEAN AREA. PATIENT HAS BEEN USING THERAPY FOR 23 YEARS WITH NO PROBLEM UNTIL USING REUSABLE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88167 ELECTRODE GEL PADS ELECTRODE GEL PADS IPF GF HEAL PRODUCTS INC. 1109001

    Patients

    Seq Age Sex Outcome Treatment
    1