BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTHERAPY

    MDR report key: 16529364 · Received March 10, 2023

    Report

    Report Number
    MW5115664
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 8, 2023
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS HAVING ULTHERAPY PERFORMED ON MY NECK AND IT FELT LIKE VERY PAINFUL ELECTRIC SHOCKS. I HAD TO TAKE SEVERAL BREAKS WHILE HAVING THE TREATMENT. I'VE NEVER EXPERIENCED THIS KIND OF PAIN WITH PREVIOUS ULTHERAPY PROCEDURES. THE TRANSPONDERS TURNED OFF AND STOPPED WORKING. THE TECHNICIAN GOT A NEW PAIR TO FINISH THE TREATMENT. THE PAIN WITH THE NEW TRANSPONDERS WAS MINIMAL AND MUCH MORE IN LINE WITH THE PAIN I FELT WITH PREVIOUS TREATMENTS. I THINK THE FIRST TRANSPONDERS WERE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445638 ULTHERAPY FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female