BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 4121353 · Received September 19, 2014

    Report

    Report Number
    3006560326-2014-00006
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    March 17, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ULTHERA INC
    Product Code
    IYO
    PMA / PMN Number
    K132028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PRACTICE REPORTED NERVE INFLAMMATION CAUSING DROOPY EYELIDS. TREATMENT DETAILS WERE REQUESTED, BUT NOT PROVIDED. AS OF (B)(6) 2014, APPROXIMATELY 8 MONTHS POST ORIGINAL TREATMENT THE PRACTICE REPORTED THAT THE PT THE BROW IS APPROXIMATELY 1MM LOWER THAN PRIOR TO TREATMENT. PRE TREATMENT PHOTOS SHOW SOME ASYMMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583456 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM IYO ULTHERA INC UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability