BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 6628912 · Received June 8, 2017

    Report

    Report Number
    3006560326-2017-00008
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    March 24, 2017
    Report Date
    June 8, 2017
    Manufacturer
    ULTHERA, INC. MERZ DEVICE INNOVATION CENTER
    Product Code
    OHV
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE ON 09-MAY-2017, 15-MAY-2017, 18-MAY-2017, 31-MAY-2017, 05-JUN-2017, 06-JUN-2017, 15-JUN-2017, 19-JUN-2017, AND 12-FEB-2019. A REVIEW OF A SUPPORT LOG FOR AN UNRELATED COMPLAINT FOUND THAT NO WARNING CODES OCCURRED ON THE TREATMENT DATE. THE SUPPORT LOG ALSO CONFIRMED THAT THESE TRANSDUCERS WERE DEPLETED OF ALL REMAINING LINES FOLLOWING SUBSEQUENT TREATMENTS AND LIKELY DISCARDED PER THE IFU. AS NO MALFUNCTIONS WERE ALLEGED TO OCCUR NOR WERE ANY MALFUNCTIONS IDENTIFIED PER A REVIEW OF THE INFORMATION PROVIDED, NO DEVICES WERE REQUESTED TO BE RETURNED FOR EVALUATION. AN EVALUATION OF THE ORIGINAL DEVICE HISTORY RECORD (DHR)/CERTIFICATE OF ANALYSIS (COFA) FOR CONTROL UNIT (B)(4) AND HAND PIECE (B)(4)FOUND NO INDICATIONS OF DEVIATIONS, REWORK, OR NONCONFORMANCE. THIS DEVICE PASSED ALL TESTS PRIOR TO RELEASE. THE SERVICE HISTORY FOR THE CONTROL UNIT WAS REVIEWED, AND FOUND THIS DEVICE HAS NOT BEEN RETURNED FOR SERVICING. THE SERVICE HISTORY FOR THE HAND PIECE INCLUDES ONE RETURN FOR SERVICING ON 07-AUG-2015 AND PASSED ALL TESTING PRIOR TO RE-RELEASE. AN EVALUATION OF THE ORIGINAL DHRS/COFAS FOR THE TRANSDUCERS RELATED TO THIS EVENT FOUND DEVIATIONS WERE ASSOCIATED WITH THE MANUFACTURING OF THE TRANSDUCERS; HOWEVER, NONE WERE LIKELY TO HAVE CONTRIBUTED TO THE REPORTED ISSUE AND ALL RELEASE SPECIFICATIONS WERE MET PRIOR TO RELEASE. THIS REPORT CONTAINS NO ALLEGATION OF A MALFUNCTION, AND BASED ON THE INFORMATION PROVIDED NO EVIDENCE OF A DEVICE MALFUNCTION COULD BE FOUND. IT IS NOT CONFIRMED WHETHER A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. A REVIEW OF THE "PATIENT MOTOR NERVE RELATED" COMPLAINT TREND ANALYSIS FOUND THAT A TREND HAS NOT BEEN IDENTIFIED AND WILL CONTINUE TO BE MONITORED. SHOULD ADDITIONAL INFORMATION REGARDING THIS EVENT BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS MADE TO OBTAIN SUPPORT LOG FROM DISTRIBUTOR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A (B)(4) AFFILIATE LOCATED IN (B)(6) REPORTED TO ULTHERA. INC, (B)(4) DEVICE INNOVATION CENTER ON (B)(6)2017 A PATIENT WHO IS EXPERIENCING FACIAL PARALYSIS OF THE RIGHT SIDE OF THE MOUTH HOURS POST ULTHERAPY TREATMENT. THE PATIENT WAS TREATED ON (B)(6) 2017 ON THE EYE AND CHEEK REGION. AS OF (B)(6) 2017 THE PHYSICIAN REPORTED TO THE AFFILIATE THAT THE PATIENT IS IMPROVING BUT IS NOT FULLY RESOLVED. SPEECH THERAPY AND PHYSIOTHERAPY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408943 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM OHV ULTHERA, INC. MERZ DEVICE INNOVATION CENTER UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability