BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROMAX

    MDR report key: 521760 · Received April 22, 2004

    Report

    Report Number
    2126518-2004-00001
    Event Type
    Other
    Date Received
    April 22, 2004
    Date of Event
    April 15, 2004
    Report Date
    April 22, 2004
    Manufacturer
    REHABILICARE INC
    Product Code
    GZJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED BURNS ON THEIR BACK AFTER ELECTRICAL STIMULATION. AFTER REMOVING ELECTRODES THERE WAS PUS BLISTERS AND SKIN COMING OFF. PT WENT TO DR THAT EVENING AND THE DOCTOR GAVE PT A CREAM TO USE ON THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMAX TENS GZJ REHABILICARE INC 4430S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other