BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 3824468 · Received April 22, 2014

    Report

    Report Number
    3006560326-2014-00002
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ULTHERA INC.
    Product Code
    OHV
    PMA / PMN Number
    K121700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT/CUSTOMER REPORTED TISSUE LOSS FROM ABOVE THE RIGHT BROW THAT OCCURRED AFTER THE ULTHERA TREATMENT. THE PT/CUSTOMER DID NOT EXPERIENCE ANY SIDE EFFECTS (BURN, WELT, SWELLING, ETC) AT THE TIME OF TREATMENT. IMMEDIATELY FOLLOWING THE ULTHERA TREATMENT, BOTOX WAS ADMINISTERED BY THE PRACTICE. THE PT HAS NEVER RECEIVED FILLER OR OTHER PROFESSIONAL TREATMENTS THAT COULD HAVE CONTRIBUTED TO THE TISSUE LOOS. THERE MAY BE RARE SIDE EFFECTS THAT WERE NOT SEEING DURING OUR CLINICAL STUDIES RELATED TO THE NEUROTOXIN ADMINISTERED IMMEDIATELY FOLLOWING THE TREATMENT. THE REPORTED ISSUE IS UNCONFIRMED IF RELATED TO ULTHERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243589 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYS OHV ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1