BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 2948150 · Received February 5, 2013

    Report

    Report Number
    3006560326-2013-00001
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    April 1, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ULTHERA INC.
    Product Code
    GEI
    PMA / PMN Number
    072505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ULTHERA TECHNICAL USER'S MANUAL STATES: POTENTIAL SIDE EFFECTS: NERVE EFFECTS: TRANSIENT LOCAL MUSCLE WEAKNESS MAY RESULT AFTER TREATMENT DUE TO INFLAMMATION OF A MOTOR NERVE. TRANSIENT NUMBNESS MAY RESULT AFTER TREATMENT DUE TO INFLAMMATION OF A SENSORY NERVE. PT SIGNED CONSENT FORM BEING NOTIFIED OF THE ABOVE POTENTIAL SIDE EFFECT PRIOR TO TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT: I HAD ULTHERAPY TREATMENT DONE ABOUT 6 WEEKS AGO AND SUFFERED NERVE DAMAGE BY THE RIGHT SIDE OF MY LOWER LIP. THE LIP IS NOW UNABLE TO DO CERTAIN MOVEMENTS LIKE PUCKER AND PUSH UP. IT HAS GOTTEN SLIGHTLY BETTER BUT HAS NEVER RETURNED TO NORMAL MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49112 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM GEI ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1