BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA, INC.

    MDR report key: 6345514 · Received February 21, 2017

    Report

    Report Number
    3006560326-2017-00003
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    February 5, 2015
    Report Date
    February 9, 2017
    Manufacturer
    ULTHERA, INC.
    Product Code
    OHV
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED FOR THE TREATMENT OF THIS PATIENT WAS A LOANER DEVICE. SINCE THE EVENT WAS REPORTED MUCH LATER THAN WHEN IT OCCURRED, THE LOANER DEVICE WAS RECERTIFIED AND THE SUPPORT LOG FROM THE DEVICE WAS UNAVAILABLE FOR REVIEW. UPON RETURN OF TALL LOANER DEVICES, THEY GO THOUGH A RECERTIFICATION PROCESS. NO DEVICE ISSUES WERE IDENTIFIED AT THE TIME OF RECERTIFICATION ACTIVITIES.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDED REPORTED TO ULTHERA ON (B)(6) 2016 THAT A PATIENT 6 MONTHS OUT FROM ULTHERA TO LIFT BROW IS EXPERIENCING CONSTANT VISIBLE TWITCHING IN THE UPPER EYE LID. THE TWITCH STARTED THE DAY AFTER TREATMENT AND HAS BEEN CONSTANT SINCE. THE HEALTH CARE PROVIDED REPORTS NO DEVIATION FROM RECOMMENDED PROTOCOL. THE HEALTH CARE PROVIDED USED LIDOCAINE WITH EPI AT THE HAIR LINE AND ABOVE THE BROW. THE HEALTH CARE PROVIDED PERSCRIBED DOXEPIN WITH NO RESPONSE. TREATMENT OF BOTOX WAS SUGGESTED TO PAITENT BUT DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128375 ULTHERA, INC. ULTHERAPY OHV ULTHERA, INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other