BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 8579557 · Received May 3, 2019

    Report

    Report Number
    3006560326-2019-00007
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Report Date
    April 4, 2019
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    UDI-DI
    00840763100827
    PMA / PMN Number
    K161885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE COULD NOT BE PERFORMED AS IT WAS DISCARDED BY THE FACILITY. THE CELLFINA DISPOSABLE KIT LOT NUMBER ASSOCIATED WITH THIS EVENT WAS PROVIDED, AND A LOT COMPLAINT HISTORY REVIEW OF THE DEVICE FOUND COMPLAINT LEVELS ON THIS LOT TO BE LESS THAN 1%. A DEVICE HISTORY REVIEW WAS PERFORMED AND DEVICES MET ALL REQUIREMENTS. NO NON-CONFORMANCE'S OR OTHER ISSUES WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A TREND ANALYSIS OF THE REPORTED ISSUE OF "BLADE BREAKS" SHOWED NO SIGNAL HAS OCCURRED WITHIN THE PAST 12 MONTHS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT WERE PERFORMED ON (B)(6) 2019; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ON (B)(6) 2019 THAT THE BLADE IN TWO CELLFINA DISPOSABLE KITS BROKE ABOUT A MINUTE INTO THE PROCEDURE. THIS IS REPORT TWO OF TWO. THE BLADE DID NOT BREAK WHILE INSERTED INTO THE PATIENT AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373425 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CK-1 2018011204 00840763100827

    Patients

    Seq Age Sex Outcome Treatment
    1