BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 3667101 · Received February 10, 2014

    Report

    Report Number
    3006560326-2014-00001
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    December 19, 2013
    Report Date
    February 10, 2014
    Manufacturer
    ULTHERA INC.
    Product Code
    OHV
    PMA / PMN Number
    K121700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PRACTICE REPORTED TO ULTHERA PRACTICE MANAGER THAT THE PATIENT HAS "LINES FROM HER TREATMENT" 1 YEAR POST ULTHERAPY. THE ORIGINAL TREATMENT WAS (B)(6) 2012. WELTS APPEARED ON HER RIGHT SIDE AFTER THE TREATMENT AND NEVER RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87689 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1