BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 3893981 · Received June 10, 2014

    Report

    Report Number
    3006560326-2014-00003
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    December 4, 2013
    Report Date
    June 2, 2014
    Manufacturer
    ULTHERA, INC.
    Product Code
    OHV
    PMA / PMN Number
    K132028
    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 THEY PERFORMED AN OFF LABEL TREATMENT OF THE INNER UPPER ARM USING THE ORANGE AND GREEN TRANSDUCERS. THE PATIENT REPORTED TO THE PRACTICE 11 DAYS POST TREATMENT NUMBNESS AND TINGLING SENSATION. THE PRACTICE REPORTED THREE NEUROLOGIES EVALUATED THE PATIENT, AND FOUND THAT THERE WAS A DIRECT NERVE BURNT OF THE SENSORY ON BOTH ARMS. NO SIGNS OF REPAIR AFTER 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343374 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA, INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability