BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 3893980 · Received June 10, 2014

    Report

    Report Number
    3006560326-2014-00004
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 7, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ULTHERA INC.
    Product Code
    OHV
    PMA / PMN Number
    K132028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE ULTHERA PRACTICE MANAGER REPORTED THE PRACTICE PERFORMED AN OFF LABEL TREATMENT OF THE ARM RESULTING IN THE PATIENTS FINGERS HURTING. THE PHYSICIAN CONFIRMED ON (B)(6) 2014 THAT THE PATIENT STILL REPORTS SHOOTING PAIN IN HER FINGER TIPS, STILL HAS PROBLEMS WITH NORMAL DAILY FUNCTION ACCORDING TO PATIENT. THE PATIENT IS SEEING A NEUROLOGIST AND WAS TOLD HAS NOW DEVELOPED CARPEL TUNNEL ON BOTH HANDS FROM THE TREATMENT. THE PHYSICIAN PROVIDED THE PATIENT WITH LYMPHATIC DRAINAGE FOR 4 TREATMENTS AND THERAPIST STATES PATIENT BETTER, PATIENT STILL COMPLAINS OF SIGNIFICANT INTERMITTENT SHOOTING PAIN IN HANDS. MULTIPLE ATTEMPTS MADE TO FOLLOW WITH NO RESPONSE FROM PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343427 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability