BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 7944859 · Received October 8, 2018

    Report

    Report Number
    3006560326-2018-00009
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    May 29, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    UDI-DI
    00840763100384
    PMA / PMN Number
    K161885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED CELLFINA MOTOR MODULE WAS PERFORMED. A VISUAL INSPECTION FOUND THAT THE CELLFINA MOTOR MODULE DID NOT SHOW ANY SIGN OF ABUSE, WEAR, TEAR, OR TAMPERING. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED AND FOUND THE MOTOR MODULE OPERATED AS INTENDED WITH NO ISSUES FOUND. AN EVALUATION OF THE COMPLAINT HISTORY FOR THIS DEVICE FOUND THERE HAS NOT BEEN ANY OTHER REPORTED COMPLAINT RECORD ASSOCIATED WITH THIS CM-1 MOTOR MODULE. AN EVALUATION OF THE ORIGINAL DEVICE HISTORY RECORD FOUND THAT THIS MOTOR MODULE WAS SUBJECT TO ONE DEVIATION; HOWEVER, THIS DEVIATION WAS RELATED TO A BOX LABEL AND WOULD NOT HAVE CONTRIBUTED TO THE REPORTED ISSUE. A SERVICE HISTORY REVIEW WAS NOT PERFORMED AS CELLFINA MOTOR MODULES ARE NOT SERVICEABLE DEVICES. THE CELLFINA DISPOSABLE KIT ASSOCIATED WITH THIS EVENT WAS DISCARDED BY THE CUSTOMER; THEREFORE, AN EVALUATION OF THIS DEVICE WAS NOT PERFORMED. THE LOT NUMBER OF THIS CELLFINA DISPOSABLE KIT WAS NOT PROVIDED BY THE FACILITY. A REVIEW OF THE REPORTED ISSUE "SCAR (MAJOR) KELOID" COMPLAINT TREND ANALYSES FOUND THAT A TREND FOR THIS CONDITION HAS NOT BEEN IDENTIFIED AND WILL CONTINUE TO BE MONITORED. THE INVESTIGATION FOUND NO EVIDENCE THE MERZ/ULTHERA DEVICES INVOLVED WITH THIS EVENT MALFUNCTIONED, AND IT IS NOT CONFIRMED WHETHER A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. HOWEVER, THE REPORTED CONDITION WAS DEEMED POTENTIALLY PERMANENT SO A DECISION TO FILE WAS MADE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, AS SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PRACTICE. THE DEVICE IS EXPECTED TO BE RETURNED FOLLOWING COMMUNICATION WITH THE PRACTICE ON (B)(6) 2018. FOLLOWING DEVICE EVALUATION ACTIVITIES, A SUPPLEMENTAL MEDWATCH FORM WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, ULTHERA, INC., MERZ DEVICE INNOVATION CENTER BECAME AWARE VIA EMAIL OF A PATIENT WHO WAS EXPERIENCING "KELOID SCARRING" AT "ENTRY POINTS" FOLLOWING A CELLFINA TREATMENT PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783189 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CM1 00840763100384

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability