BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 2403811 · Received January 5, 2012

    Report

    Report Number
    3006560326-2012-00001
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 4, 2012
    Manufacturer
    ULTHERA, INC.
    Product Code
    GEI
    PMA / PMN Number
    072505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO ULTHERA FOR EVALUATION. CAUSE OF EVENT IS MOST LIKELY DUE TO TREATMENT TECHNIQUE ERROR. CLINICIAN PERFORMING THE TREATMENT WILL BE RETRAINED.

    Description of Event or Problem · 1

    THE PT CALLED ULTHERA SIX MONTHS AFTER RECEIVING AN ULTHERAPY TREATMENT TO REPORT AN ADVERSE EVENT. THE PT STATED THAT SHE BRUISES EASILY AND SIX MONTHS POST TREATMENT, SHE HAS FIVE OR SIX AREAS OF SLIGHT LINEAR DEPRESSIONS WITH SOME DISCOLORATION. SHE REPORTS USING BLEACHING CREAM FOR THE DISCOLORATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other