BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 2948152 · Received February 5, 2013

    Report

    Report Number
    3006560326-2013-00003
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    July 31, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ULTHERA INC.
    Product Code
    GEI
    PMA / PMN Number
    072505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ULTHERA TECHNICAL USER'S MANUAL: 2.3 PRECAUTIONS. TREATMENT ENERGY IS NOT RECOMMENDED FOR USE DIRECTLY ON AN EXISTING KELOID.

    Description of Event or Problem · 1

    IT WAS REPORTED: PT - HAS BLISTERS. CLEARING UP NICELY, HOWEVER THE PT IS PRONE TO KELOID SCARING. SHE HAS OLIVE TONE - SO THEY WILL GIVE HER HYDRO CORTISONE AFTER HER BLISTERS HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48770 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM GEI ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1