BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3875052 · Received June 10, 2014

    Report

    Report Number
    2135225-2014-00037
    Event Type
    Other
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S RECOVERY STATUS WAS REQUESTED AND NOT RECEIVED. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS INJECTED WITH ONE SYRINGE OF RADIESSE INTO MIDFACE. ABOUT THREE WEEKS LATER, THE PATIENT DEVELOPED PAIN, REDNESS, TENDERNESS, SWELLING AND A NODULE IN THE RIGHT TEAR TROUGH AREA. DR (B)(6) DIAGNOSED THE PATIENT WITH INFECTION AND TREATED HER WITH ORAL LEVOFLOXACIN, FOLLOWED BY ORAL CLINDAMYCIN, DOSES, FREQUENCIES AND DURATIONS WERE UNKNOWN AT THE TIME OF CALL. THE PATIENT WAS ALSO INJECTED WITH HYALURONIDASE INTO THE AFFECTED AREA. THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340906 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100071402

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention 0.3 CC LIDOCAINE MIXED WITH RADIESSE