BEUDAMED
    FDA Adverse Event Other Summary report: N

    DU PEL DUAL CHANNEL IONTOPHORETIC DEVICE

    MDR report key: 112666 · Received July 22, 1997

    Report

    Report Number
    112666
    Event Type
    Other
    Date Received
    July 22, 1997
    Date of Event
    May 14, 1997
    Report Date
    May 19, 1997
    Manufacturer
    EMPI, INC.
    Product Code
    EGJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING IONTOPHORESIS TO RIGHT WRIST. PT HAS RECEIVED 4.0 M/AMPS AND THE MACHINE HAD PEEPED, AT THAT TIME PT. STATED HE FELT A BURNING SENSATION TO WRIST. MACHINE WAS TURNED OFF AND ELECTRODES AND PADS REMOVED. ICE WAS ADMINISTERED TO WRIST. PT WAS TAKEN TO EMERGENCY ROOM AND TREATED FOR A SUPERFICIAL BURN TO RIGHT WRIST AT MP JOINT OF THUMB. ON DORSAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DU PEL DUAL CHANNEL IONTOPHORETIC DEVICE IONTOPHORETIC DEVICE EGJ EMPI, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other