BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 6185480 · Received December 14, 2016

    Report

    Report Number
    MW5066757
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    October 11, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ULTHERA
    Product Code
    OHV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD TREATMENT DONE BY STEP FROM ULTHERA. A COUPLE OF DAYS AFTER, I NOTICED WRINKLES, A MONTH LATER I NOTICED MORE NOW, I HAVE HUGE BAGS UNDER MY EYES, MY VISION IS BLURRY, DRY SKIN SAGGING. I LOOK 15 YEARS OLDER. I HAVE NERVE DAMAGE AND MY HAIR FALLING OUT, I HAVE MAJOR FAT LOSS TO MY FACE AND LOOSE SKIN, EVERY DAY LOOKS WORSE. I'M SO SAD I CAN'T STOP CRYING. I DIDN'T DO RESEARCH BUT SAW ONLINE IT RUINED A LOT OF LIVES AND I'M ONE OF THEM, I'M A SINGLE MOM, (B)(6) AND I ALWAYS BEEN TOLD I LOOK 21. I DIDN'T NEED TREATMENT, I JUST DID FOR PREVENTIVE AS THEY SAID IT WOULD HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823578 ULTHERA ULTHERA OHV ULTHERA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other OTC MEDS: RESVERATROL| RX MEDS: ARMOR THYROID