BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IONITHERMIE MIT485, MACHINE DRIVEN BODY TREATMENT

    MDR report key: 1378537 · Received May 8, 2009

    Report

    Report Number
    MW5011034
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    April 11, 2009
    Report Date
    April 23, 2009
    Manufacturer
    IONITHERMIE US
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A BODY TREATMENT AT EQUINOX FITNESS CLUB AND SPA WHILE TRAVELING. THE TREATMENT IS CALLED IONITHERMIE AND CLAIMS TO CAUSE INCH LOSS AND REMOVE CELLULITE IN ONE SESSION USING ELECTRICAL STIMULI AND IONIZATION. THE SESSION LEFT ME FEELING SICK AND CAUSED GALVANIC BURNS TO MY SKIN. THE MACHINE IS NOT EVEN REGISTERED TO BE IN THE US. DATES OF USE: 2009 - 60 MINUTE SESSION. EVENT ABATED AFTER USE STOPPED: YES. PULL UP THE 'BROCHURE' UNDER 'TREATMENTS' LINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONITHERMIE MIT485, MACHINE DRIVEN BODY TREATMENT IONITHERMIE IRT IONITHERMIE US NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention