BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 5032598 · Received August 20, 2015

    Report

    Report Number
    MW5055743
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    February 17, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ULTHERA
    Product Code
    OHV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ULTHERAPY PROCEDURE USING ULTHERA SKIN TIGHTENING DEVICE ON (B)(6) 2015. AREA TREATED WAS THE NECK. PROCEDURE WENT NORMALLY. ON (B)(6) 2015 PATIENT REPORTED WELTS ON HER NECK, WHICH ARE COMMON AFTER THIS PROCEDURE. ON (B)(6) 2015 STILL HAD WELTS, UT THESE WERE SUBSIDING. ON (B)(6) 2015 PATIENT REPORTED: ANTERIOR CERVICAL SKIN CHANGES AFTER PROCEDURE. SKIN SURFACE IRREGULARITY; TIGHTNESS IN THE NECK, PARTICULARLY, AT THE RIGHT PLATYSMAL BAND LOCATION. NOTICES TIGHTNESS WHEN LIFTING CHIN UP; TONGUE 'BURNING' OR PAIN LOCATED ON UNDERSURFACES OF TONGUE ANTERIORLY; 'TINGLING' CHANGE IN SENSATION LOWER LIP CENTRAL. EXAMINATION REVEALED NO ABNORMALITIES IN CRANIAL NERVE FUNCTION OR INTRAORAL LESIONS. SOME SUBTLE SWELLING OF THE SKIN WAS STILL EVIDENT. ON (B)(6) 2015 PATIENT REPORTED THAT SHE HAD A PULLING SENSATION OF HER TONGUE MAKING IT DIFFICULT TO TALK. THE DEVICE MANUFACTURER WAS NOTIFIED AND THE MEDICAL DIRECTOR WAS CONSULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551380 ULTHERA ULTHERA OHV ULTHERA REF

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other