BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERAPY

    MDR report key: 5383910 · Received January 16, 2016

    Report

    Report Number
    MW5059505
    Event Type
    Injury
    Date Received
    January 16, 2016
    Date of Event
    January 10, 2014
    Report Date
    January 16, 2016
    Manufacturer
    ULTHERA, INC.
    Product Code
    OHV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD PERMANENT AND SUBSTANTIAL DAMAGE TO MY FACE AFTER UNDERGOING AN ULTHERAPY TREATMENT IN A PLASTIC SURGEONS OFFICE. I EXPERIENCED HEALTHY FAT LOSS, MUSCLE ATROPHY/LAXITY AND PERMANENT EYE SHAPE CHANGE (EYEBALL AND EYELID RETRACTION). THERE WAS NO 'SKIN TIGHTENING' AS INTENDED, JUST TOTAL DAMAGE TO UNDERLYING TISSUE. ULTHERAPY IS A PRODUCT OF ULTHERA INC, (B)(4), AND IS AN ULTRASOUND TECHNOLOGY THAT IS CURRENTLY APPROVED BY THE FDA FOR SKIN TIGHTENING/LIFTING AND ADVERTISED AS SAFE AND WITHOUT RISK. UNFORTUNATELY, MANY WOMEN ARE NOW CLAIMING, ON CONSUMER REVIEW SITES, THAT THEY TOO HAVE EXPERIENCED SEVERE DAMAGE AND SIDE EFFECTS. IT DAMAGES UNDERLYING TISSUE TO THE POINT OF DESTRUCTION, FAT LOSS AND MUSCLE ATROPHY ALTERING APPEARANCES DRAMATICALLY. I AM CURRENTLY LISTED AS A WILLING PARTY ON A POTENTIAL CLASS ACTION LAW SUIT, THAT IS GAINING PARTICIPANTS TO MOVE FORWARD. PLEASE ADDRESS THIS COMPLAINT, THIS IS A VERY SERIOUS RISK TO UNSUSPECTING PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30638 ULTHERAPY ULTHERAPY OHV ULTHERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability