BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2142933 · Received June 23, 2011

    Report

    Report Number
    3003496686-2011-38785
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO WAS RECEIVED FROM A CONSUMER ON (B)(6) 2011: A (B)(6) FEMALE CONSUMER WITH NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN VASCULAR DISEASE HAD ONE TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNK, EXPIRATION DATE UNK) ON (B)(6) 2011 FOR COSMETIC USE. SHE RECEIVED TWO VIALS OF POLY-L-LACTIC ACID ON HER NASOLABIAL FOLDS AND CHEEK LINES. SHE REPORTED THAT SHE HAD THREE LUMPS OR "CYSTS" THAT FORMED ON HER RIGHT CHEEK AFTER HAVING HER INJECTIONS. THE LUMPS BEGAN APPEARING WITHIN TWO WEEKS OF THE INJECTIONS ((B)(6) 2011). THE LUMPS FELT HARD AND SHARP LIKE A RAZOR UNDER THE SKIN. THE THREE LUMPS FORM A TRIANGLE ON HER CHEEK IN THE AREA THAT WAS DIRECTLY TO THE SIDE OF THE FLARE OF HER NOSE AND DIRECTLY BELOW HER EYE. THE LARGEST LUMP WAS BIGGER THAN THE SIZE OF A PEA, THE SECOND LUMP IS ABOUT THE SIZE OF A GRAIN OF RICE, AND THE SMALLEST LUMP WAS TINY, BUT VISIBLE. THE AREA AROUND THE LARGEST LUMP HAD BECOME DISCOLORED AND IS DARKER THAN HER SKIN. WHEN SHE WAS PATTING THE AREA DRY A FEW DAYS AGO, IT ALSO BLED A LITTLE. THE LUMPS WERE VERY VISIBLE AND PEOPLE EVEN ASK HER WHAT HAPPENED TO HER. THE LOCATIONS OF THE LUMPS WERE AT SOME INJECTION SITE BUT NOT ALL OF THEM. THERE WAS NO EVIDENCE OF SYSTEMIC PROCESS. A BIOPSY WAS NOT PERFORMED. THE HOLLOW OF HER RIGHT CHEEK WAS ALSO VERY LUMPY AFTER THE INJECTIONS, BUT THAT AREA SEEMED HAVE GOTTEN BETTER. NONE OF THE LUMPS WERE VISIBLE ANYMORE AND THEY SEEM TO BE GOING DOWN IN SIZE. THE LEFT SIDE OF FACE LOOKED GREAT. SHE ALSO STATED THAT IT WAS VERY HARD FOR HER TO MASSAGE HER SKIN AFTER THE INJECTIONS. HER WHOLE FACE, ESPECIALLY THE RIGHT SIDE WAS VERY SORE AFTER THE INJECTIONS. HER PHYSICIAN WAS AWARE OF SITUATION. THE PHYSICIAN TRIED TO IRRIGATE IT WITH SALINE (LESIONAL SUNCISION) AND SHE ALSO TOOK A ROUND OF STEROIDS AND WAS CURRENTLY TAKING ANTIBIOTICS. AT THE TIME OF THE REPORT, THE LUMPS WERE ONGOING DESPITE THE FACT THAT THEY ARE NO LONGER VISIBLE. THE DURATION WAS NOT CHARACTERIZED AS PROTRACTED OR PROLONGED. THERE WAS NO EVIDENCE OF PERMANENT IMPAIRMENT OF A BODY FUNCTION. SHE DID NOT EXPECT THE EVENTS TO BE IRREVERSIBLE. THE TREATMENT WAS NOT GIVEN TO PRECLUDE PERMANENT IMPAIRMENT OF BODY FUNCTION OR DAMAGE TO BODY STRUCTURE. NO FURTHER RELEVANT INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other CON MEDS = UNK| PREV MEDS = UNK