BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 5005267 · Received August 14, 2015

    Report

    Report Number
    3006560326-2015-00005
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    October 24, 2014
    Report Date
    August 14, 2015
    Manufacturer
    ULTHERA
    Product Code
    OHV
    PMA / PMN Number
    K132028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION SUSPECTED.

    Description of Event or Problem · 1

    MARCH 21, 2015 THE PROVIDER REPORTED A PATIENT WITH NUMBNESS AROUND HER LIPS AND MOUTH "FROM THE TREATMENT" ON (B)(6) 2014. AT THE TIME OF REPORT THE PATIENT REPORTED NORMAL MOVEMENT WITH NUMBNESS AND TINGLING SENSATION. THE PATIENT DISCLOSED TO THE PROVIDER THAT SHE HAS BEEN TO A FEW DOCTORS THAT TESTED HER FOR AUTO IMMUNE ISSUES, ALLERGIES ETC.. THE ULTHERA MEDICAL DIRECTOR FEELS THIS ISSUE WILL RESOLVE, BUT NEEDS MORE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540349 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other