BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERAPY; AKA ULTHERA SYSTEM

    MDR report key: 8793245 · Received July 15, 2019

    Report

    Report Number
    MW5088119
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    November 2, 2016
    Report Date
    June 11, 2019
    Manufacturer
    ULTHERA, INC.
    Product Code
    OHV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMINISTERED ULTHERAPY (FOCUSED ULTRASOUND) TO HER ENTIRE FACE, IN AMOUNTS FAR EXCEEDING THE RECOMMENDATION OF MERZ NO. AMERICA, THE COMPANY WHICH MARKETS THE ULTHERAPY DEVICE. PT HAS SUFFERED SIGNIFICANT FACIAL DAMAGE, INCLUDING LOSS OF AT LEAST 80% OF HER FACIAL FAT. MY CLIENT HAS SUFFERED SEVERE DAMAGE TO HER FACE, INCLUDING SIGNIFICANT LOSS OF FACIAL FAT, INTERMITTENT BLEPHAROSPASM, PERMANENT HYPOESTHESIA, CHRONIC JAW PAIN, NASAL VALVE COLLAPSE AND BREATHING DIFFICULTY WHICH HAS BEEN ATTRIBUTED TO ULTHERAPY BY DR (B)(6), A LICENSED, BOARD CERTIFIED PLASTIC SURGEON. A COPY OF HIS REPORT IS ENCLOSED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584510 ULTHERAPY; AKA ULTHERA SYSTEM FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV ULTHERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability