BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOGEL

    MDR report key: 1394226 · Received May 22, 2009

    Report

    Report Number
    1022819-2009-00147
    Event Type
    Injury
    Date Received
    May 22, 2009
    Date of Event
    March 6, 2009
    Report Date
    April 29, 2009
    Product Code
    KTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN DURING AN IONTOPHORESIS TREATMENT ON THE KNEE. THE MEDICATION USED WAS DEXAMETHIZONE. THE DOSAGE WAS 4.0 FOR 10 MINUTES. THE BURN OCCURRED UNDER ONE ELECTRODE WHERE THE METAL SNAP IS LOCATED ON THE DISPERSIVE ELECTRODE. THE BURN WAS THIRD DEGREE AND DID REQUIRE DAILY WOUND CARE. THIS WAS THE PATIENT'S FIRST IONTOPHORESIS TREATMENT. THE THERAPIST COULD NOT PROVIDE THE MODEL NUMBER OR THE ELECTRODE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOGEL KTB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other