BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 2948151 · Received February 5, 2013

    Report

    Report Number
    3006560326-2013-00002
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    July 26, 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

    Description of Event or Problem · 1

    IT WAS REPORTED: VERY SMALL WELT ON PTS LEFT NECK. IMMEDIATELY BEGAN TO ICE. AS OF (B)(6) 2013 STILL HAVE SCAR WHERE ONE OF WELTS/BLISTERS WAS. ALL OTHERS SEEM TO HAVE GONE AWAY BUT CAN STILL KIND OF SEE. RAISED A LITTLE, LOOKS LIKE A LINE. THERE WAS 8. BEEN THE SAME FOR 2 AND A HALF MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47738 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM GEI ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1