BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 2192018 · Received July 29, 2011

    Report

    Report Number
    3002807108-2011-47939
    Date Received
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS RECEIVED FROM CONSUMER ON (B)(6) 2011: A FEMALE CONSUMER RECEIVED POLY-L-LACTIC ACID (SCULPTRA) INJECTIONS IN (B)(6) 2009 AND TWICE IN (B)(6) 2010. THE CONSUMER REPORTED THAT HARD NODULES HAVE FORMED ON BOTH SIDES OF HER MOUTH, CHIN, ALONG THE JAW LINE, AND IN A FEW OTHER AREAS. MOST OF THESE WERE VISIBLE. THE PLASTIC SURGEON WHO INJECTED THE POLY-L-LACTIC ACID, HAS ATTEMPTED TO TREAT SOME OF THESE NODULES BY INJECTING STEROIDS. THERE IS AN INITIAL SOFTENING AND SLIGHT DECREASE IN SIZE, BUT THE TREATED NODULES HAVE RESUMED THEIR SIZE AND HARDNESS. SOME OF THE UNTREATED NODULES CONTINUE TO GROW AND NEW ONES SEEM TO BE ARISING. THE CONSUMER REPORTED THAT THE UNTREATED NODULES WERE CAUSING A GREAT DEAL OF STRESS AND ANXIETY. NO FURTHER RELEVANT INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN