BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 6909733 · Received October 3, 2017

    Report

    Report Number
    3006560326-2017-00007
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    September 24, 2016
    Report Date
    January 19, 2017
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OHV
    UDI-DI
    00840763100247
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ULTHERAPY UC-1 CONTROL UNIT AND UH-2 HANDPIECE WERE RETURNED FOR SERVICE AND REPAIR ON 23-AUG-2018. AN EVALUATION OF THE RETURNED PRODUCT WAS PERFORMED, AND NO ISSUES WERE IDENTIFIED. THE SYSTEM UNDERWENT AN OPERATING SYSTEM UPDATE AND THEN PASSED ALL TESTS PRIOR TO RELEASE. NO ISSUES WERE ALLEGED NOR IDENTIFIED TO OCCUR ON THE TRANSDUCERS USED DURING THE TREATMENT. THESE TRANSDUCERS WERE NOT REQUESTED BACK FOR EVALUATION AS THEY WERE CONFIRMED TO BE USED TO COMPLETION FOLLOWING TREATMENT WITH SUBSEQUENT PATIENTS. A REVIEW OF THE COMPLAINT DEVICE SUPPORT LOG FOUND THAT THE ONLY SYSTEM MESSAGES DISPLAYED WERE CODE L INDICATING TRANSDUCER OUT OF LINES. THE INVESTIGATION SUGGESTS THAT THE DEVICE PERFORMED AS INTENDED DURING THE PROCEDURE. IT IS UNCONFIRMED WHETHER A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE AFFILIATE CONFIRMED ON (B)(6) 2019 THAT THIS PATIENT FULLY RESOLVED.

    Additional Manufacturer Narrative · 1

    THE SYSTEM SUPPORT LOG WAS REVIEWED WITH NO ANOMALIES OR WARNINGS IDENTIFIED. BASED ON THE SUPPORT LOG REVIEW, THE PHYSICAL DEVICE HAS BEEN REQUESTED FOR EVALUATION AT THIS TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS EVENT WAS IDENTIFIED AS BEING REPORTABLE AS A RESULT OF A REVIEW OF COMPLAINTS RECEIVED BY ULTHERA, INC. MERZ DEVICE INNOVATION CENTER. THIS SUBMISSION IS PART OF A CORRECTION DOCUMENTED IN ULTHERA, INC., MERZ DEVICE INNOVATION CENTER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 A MERZ AFFILIATE LOCATED IN (B)(6) REPORTED THAT A FEMALE PATIENT HAD EXPERIENCED SENSORY NERVE PAIN THREE MONTHS POST A FULL FACE ULTHERAPY TREATMENT ADMINISTERED WITH CONTROL UNIT SERIAL NUMBER (B)(4). THE PATIENT WAS TREATED ON (B)(6) 2016 WITH THE STANDARD RECOMMENDED PROTOCOL WITH INCREASED ENERGY. THE PATIENT EXPERIENCED A "SHOCK LIKE SENSATION" ON THE LEFT SIDE OF HER FOREHEAD DURING TREATMENT BUT DID NOT MAKE THE PROVIDER AWARE OF THE PAIN AT THE TIME OF TREATMENT. THREE MONTHS LATER THE PATIENT SOUGHT TREATMENT (PHYSICIAN NAME NOT PROVIDED) FROM A SPECIALIST BECAUSE THE "SHOCK LIKE SENSATION" DID NOT SUBSIDE. THE SPECIALIST DIAGNOSED THE PATIENT WITH TRIGEMINAL NEURALGIA AND PRESCRIBED 300 MG OF GABAPENTIN FOR HER SYMPTOMS. THE AFFILIATE REPORTS THE PATIENT IS 80% RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690178 ULTHERA SYSTEM ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA, INC., MERZ DEVICE INNOVATION CENTER UC-1 00840763100247

    Patients

    Seq Age Sex Outcome Treatment
    1 Other