BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 6822692 · Received August 25, 2017

    Report

    Report Number
    3006560326-2017-00012
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 1, 2017
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    PMA / PMN Number
    K161885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF PRODUCT WAS NOT PERFORMED BECAUSE INFORMATION TO CONFIRM DEVICE LOT/SERIAL NUMBERS USED WAS NOT PROVIDED BY THE TREATING OFFICE DESPITE FIVE DOCUMENTED ATTEMPTS ON 8/4/2017 (ONE PHONE CALL, ONE E-MAIL), 8/9/2017 (ONE PHONE CALL, ONE E-MAIL), AND 8/23/2017 (AN IN-PERSON VISIT BY MERZ EMPLOYEE). A MALFUNCTION OF THE DEVICE WAS UNABLE TO BE CONFIRMED. IT CANNOT BE CONFIRMED WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ULTHERA, INC. BECAME AWARE OF A PATIENT COMPLAINT ON 8/01/2017 OF A BLOG POSTING CREATED ON 7/14/2017. THE PATIENT ALLEGES THAT THEY RECEIVED A CELLFINA TREATMENT (DEVICE SERIAL NUMBER NOT PROVIDED) ON (B)(6) 2017. IN SUBSEQUENT COMMENTS TO HER BLOG POSTING, THE PATIENT STATES THAT SHE EXPERIENCED PAIN AND BRUISING FOR WHICH SHE SOUGHT SUBSEQUENT TREATMENT TO HAVE SEROMA/HEMATOMAS DRAINED. THE PATIENT ALSO STATES THAT SHE WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602505 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC., MERZ DEVICE INNOVATION CENTER CM-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other