BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTOPHORESIS GROUNDER PATCH

    MDR report key: 37100 · Received August 6, 1996

    Report

    Report Number
    37100
    Event Type
    Other
    Date Received
    August 6, 1996
    Date of Event
    March 3, 1996
    Report Date
    March 11, 1996
    Manufacturer
    LIFE TECH, INC.
    Product Code
    KTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    A NEW TYPE OF IONTOPHORESIS GROUNDER PATCH WAS SET UP USING 1CC OF DEXAMETHASONE, .25CC EPINEPHRINE, AND 1CC LIDOCAINE IN THE ELECTRODES USED TO TRANSFER THE MEDICATIONS. A NEW TRIAL PAD WAS PLACED ON THE PT'S UPPER ARM AND THE "+" CHARGE STARTED. PT TOLERATED CURRENT 4.00 WHEN THE "-" DOSE WAS STARTED AND REACHED .51. PT COMPLAINED IT WAS BURNING HER ARM. TREATMENT IMMEDIATELY STOPPED. PT RECEIVED FIRST DEGREE BURN WHERE PATCH WAS ATTACHED. AFFECTED AREA ICED - EXAMINED IN ER. SYMPTOMS GONE BY THE END OF DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORESIS GROUNDER PATCH IONTOPHORESIS GROUNDER PATCH KTB LIFE TECH, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other