BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 6909760 · Received October 3, 2017

    Report

    Report Number
    3006560326-2017-00013
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    July 23, 2015
    Report Date
    July 24, 2015
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OHV
    UDI-DI
    00840763100179
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER PERFORMED THE INVESTIGATION OF THE DEVICES ASSOCIATED WITH THIS PATIENT EVENT. THESE DEVICES INCLUDE A CONTROL UNIT AND HANDPIECE THAT WERE RECEIVED AT THE FACILITY ON (B)(6) 2015, AS WELL AS A TRANSDUCER THAT WAS RECEIVED AT THE FACILITY ON (B)(6) 2015. A SUPPORT LOG REVIEW FROM THE ULTHERA CONTROL UNIT FOUND MULTIPLE INSTANCES OF CODE J, AS WELL AS AN INSTANCE OF A MISSING LOG. THERAPY TESTS/TCPS WERE ALL FUNCTIONING WITHIN NORMAL RANGES. SOFTWARE ISSUE COULD NOT BE DUPLICATED AND ALL TESTS WERE PASSED. ACOUSTIC POWER SPECIFICATION WAS FOUND TO BE WITHIN SPECIFICATION. NO IMAGE ISSUES WERE FOUND. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. 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 CAPA-(B)(4). (B)(4).

    Description of Event or Problem · 1

    A MERZ AFFILIATE LOCATED IN (B)(6) NOTIFIED ULTHERA INC., MERZ DEVICE INNOVATION CENTER ON (B)(6) 2015 ABOUT A PATIENT WHO ALLEGEDLY EXPERIENCED THIRD-DEGREE BURNS FOLLOWING AN ULTHERAPY TREATMENT WITH TRANSDUCER SERIAL NUMBER (B)(4), HANDPIECE SERIAL NUMBER (B)(4), AND CONTROL UNIT SERIAL NUMBER (B)(4). THE TREATMENT WAS REPORTEDLY PERFORMED UNDER ANESTHESIA AND RESULTED IN SCARRING ON THE LEFT CHEEK WITH SWELLING IN THE NECK FOR APPROXIMATELY 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690495 ULTHERA SYSTEM ULTHERA SYSTEM OHV ULTHERA, INC., MERZ DEVICE INNOVATION CENTER UC-1 00840763100179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other