BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 4121367 · Received September 19, 2014

    Report

    Report Number
    3006560326-2014-00008
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    June 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ULTHERA INC.
    Product Code
    IYO
    PMA / PMN Number
    K132028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE PT REPORTED TO ULTHERA: NECK AND LOWER JAW TREATMENT IN (B)(6) 2014 RESULTED IN EYES ARE TWITCHING THEN SPREAD THROUGH THE FACE SINCE 2 DAYS POST TREATMENT. THE FACE HAS RESOLVED, BUT EYES HAVE NOT. PHYSICIAN CONFIRMED PT HAS MARGINAL MANDIBULAR NERVE PALSY AND ANTICIPATES RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583506 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM IYO ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability