BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERAPY

    MDR report key: 7910517 · Received September 25, 2018

    Report

    Report Number
    MW5080133
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    February 27, 2018
    Report Date
    September 24, 2018
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED ULTHERAPY ON MY FACE AND NECK. WAS TOLD IT WAS NON-INVASIVE HEATED ULTRASOUND TO LIFT TIGHTEN AND TONE. ITS MAIN THING IS TO STIMULATE COLLAGEN. I WAS TOLD ONLY SIDE EFFECTS COULD BE MILD DISCOMFORT AND POSSIBLY NOT A NOTICEABLE DIFFERENCE. RESULTS ARE SUPPOSED TO SHOW 3-6 MONTH. AT 2 MONTHS I NOTICED CHANGES, BY 4 MONTHS MY FACE HAD BEEN DEPLETED OF FAT, AND I¿M LEFT WITH DEEP HOLLOWS AND NERVE DAMAGE. I WAS TOLD IT DOESN¿T TOUCH YOUR FAT LAYER. I¿VE SINCE DISCOVERED IT CAN, AND HEATED ULTRASOUND IS ACTUALLY USED TO DEPLETE FAT AND DESTROY CELLS IN OTHER SITUATIONS. I WAS ALSO TOLD IT WAS FDA APPROVED, BUT LATER LEARNED IT IS NOT FOR THE FACE. IT IS ADVERTISED FOR ENTIRE FACE WITH NO WARNING OF NERVE DAMAGE AND FAT LOSS. I¿M PHYSICALLY AND EMOTIONALLY DAMAGED. I¿M SCARED OF WHAT ELSE IT¿S DONE THAT CAN¿T BE SEEN AS I HAVE TUGGING, VIBRATING AND ACHING FEELINGS IN FACE. I¿VE BEEN TO DOCTORS MULTIPLE TIMES AND HAVE BEEN TOLD I HAVE NERVE DAMAGE AND AM SEEING A NEUROLOGIST NEXT WEEK. I¿M PREGNANT NOW AND CAN'T TAKE RECOMMENDED MEDICATION FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746669 ULTHERAPY FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR OHV MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR