BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 3893987 · Received June 10, 2014

    Report

    Report Number
    3006560326-2014-00005
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 17, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE PRACTICE REPORTED THEY PERFORMED AN OFF LABEL TREATMENT: THE PRACTICE INQUIRED (B)(6) 2013 TO MEDINFO AND RECEIVED INFORMATION ON OFF LABEL ELBOW TREATMENT FROM ULTHERA. (B)(6) PROCEEDED TO TREAT A PATIENT ON (B)(6) 2013 ABOVE THE ELBOW. THE PATIENT HAS EXPERIENCED NUMBNESS AND SIGNIFICANT PAIN WHEN USING FINGERS (TYPING FOR EXAMPLE) - SPECIFICALLY THE PINKY AND RING FINGERS. THE PATIENT HAS SEEN A NEUROLOGIST AND HAD A NERVE CONDUCTION STUDY. THE ULNAR NERVE IS NOT DAMAGED, HOWEVER THE MYLAR SHEATHING THE PATHWAY HAS DAMAGE. THE PATIENT WAS PUT ON HIGH DOSES OF GABAPENTIN AND HYDROCODONE. THE PRACTICE SAW THE PATIENT FOR THE FIRST TIME (B)(6) 2014 FOR FOLLOW-UP-SHE HAD NOT COME IN BEFORE THEN BECAUSE SHE WAS SEEING THE SPECIALIST. THE PATIENT CONTACTED ULTHERA DIRECT, SHARING THAT SOUGHT THE TREATMENT OF A NEUROLOGIST IN EARLY DECEMBER. SHE WAS ON DAILY PRESCRIPTION PAIN MEDICATION FOR WEEKS AS WELL AS THE HIGHEST ALLOWABLE DOSAGE OF NEURONTIN IN ORDER TO MANAGE AND RECOVER FROM THE ULNAR NEUROPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343385 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability