BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 10153015 · Received June 12, 2020

    Report

    Report Number
    MW5094978
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    April 20, 2015
    Report Date
    June 10, 2020
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ULTHERAPY, ENCEPHALOPATHY; 6 MOS AFTER TREATMENT, NERVES ATTACKED TISSUE. ALTERED MENTAL STATE. LOSS OF MOTOR SKILLS AND VISION. SKIN TISSUE, EYES, LIDS BURNED OFF. I COULD NOT BREATHE. STAYED IN CRITICAL CONDITION 19 MOS. SEVERE BRAIN DAMAGE AS A RESULT. CURE WAS A BOTTLE OF GABAPENTIN. DAY 1, MERZ PHARMA AND SPA REFUSED TO HELP OR REPORT LIFE THREATENING REACTION. DAMAGE TO BRAIN AND FRONTAL LOBE. I HAVE NO HISTORY OF MENTAL ILLNESS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610764 ULTHERA FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| S