BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2218179 · Received August 10, 2011

    Report

    Report Number
    2135225-2011-00078
    Event Type
    Other
    Date Received
    August 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MERZ AESTHETICS, 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

    DR. (B)(6) WAS NOT THE RADIESSE DERMAL FILLER INJECTOR, BUT IS PROVIDING TREATMENT FOR THE PATIENT; HE DOES NOT HAVE ACCESS TO THE PATIENT'S INJECTION DETAILS INCLUDING THE AMOUNT, RADIESSE LOT NUMBER, ETC. THEREFORE THE DEVICE HISTORY RECORDS CANNOT BE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER AT A MEDICAL SPA (NO LONGER IN BUSINESS) ALONG THE CHEEK BONES AND IN THE TEAR TROUGHS IN (B)(6) 2010. ONE MONTH AFTER THE INJECTION ((B)(6) 2011), THE PATIENT WAS HIT IN THE FACE WITH A BASEBALL. THE PATIENT DEVELOPED A VERY PRONOUNCED CONICAL SHAPED LUMP UNDER HER RIGHT EYE. ONE PHYSICIAN SUGGESTED INCISION, BUT SHE HAD REFUSED. SINCE THAT TIME, THE AREA HAS SHRUNK ABOUT 50% AND IS SOFT WITH PALPABLE MASSES, BUT STILL VERY VISIBLE. DR. (B)(6) INJECTED KENALOG-10 TO SETTLE INFLAMMATION AND LASER FRAXEL DUEL-1927 TO TAKE SOME OF THE PIH (POST INFLAMMATORY HYPERPIGMENTATION) OUT OF THE SKIN. HE WOULD LIKE TO SPEAK WITH ONE OF THE MEDICAL DIRECTORS TO DISCUSS OTHER OPTIONS. THE PATIENT WAS PRESCRIBED A DOUBLE-DOSE ANTIBIOTIC IN (B)(6) 2011, AND THE LUMP HAS DECREASED. THERE IS STILL A VISIBLE PROTRUSION BUT IT IS MUCH SMALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention