BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMP+

    MDR report key: 470935 · Received July 11, 2003

    Report

    Report Number
    2126518-2003-00001
    Event Type
    Other
    Date Received
    July 11, 2003
    Date of Event
    June 13, 2003
    Report Date
    July 11, 2003
    Manufacturer
    REHABILICARE, INC
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REMOVED ELECTRODES FROM BUTTOCKS AND ONE OF THE FOUR ELECTORDES TOOK TOP LAYER OF SKIN OFF. PHYSICIAN PRESCRIBED "DUODERM" DRESSING TO AREA, AND PT REPORTED "ULCER" OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMP+ TENS UNIT GZJ REHABILICARE, INC 4920S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other