BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2803063 · Received October 19, 2012

    Report

    Report Number
    3002807108-2012-75919
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    March 1, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2012. A (B)(6) FEMALE CONSUMER REPORTED SHE RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) IN (B)(6) 2012, "HALF VIAL" PER CHEEK AND AGAIN TWO MONTHS LATER IN (B)(6) 2012 WITH SAME AMOUNT FOR COSMETIC PURPOSES. SHE REPORTED THE FIRST TIME IN (B)(6) 2012; SHE EXPERIENCED BRUISING AND SOME SWELLING AFTER HER INJECTIONS, BUT IT WENT AWAY IN A FEW DAYS, SHE REPORTED THE BRUISES WERE HUGE QUARTER SIZE BRUISES. SHE REPORTED THE SECOND INJECTIONS IN (B)(6) 2012, SHE EXPERIENCE SWELLING IN BOTH CHEEK AREAS WHICH HAS LASTED UNTIL NOW, SHE REPORTED WHEN SHE SMILES SHE LOOK LIKE SHE HAS CHIPMUNK CHEEKS. SHE REPORTED THE PLASTIC SURGEON TOLD HER THE SCULPTRA AESTHETIC WOULD REMAIN IN HER FACE FOR OVER FOUR YEARS. SHE ALSO REPORTED AS OF TODAY, HER SYMPTOMS ARE CONTINUING AND SHE WILL NOT CONTINUE HER THERAPY. NO MEDICAL HISTORY OR CONCOMITANT MEDICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS 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 49 YR Other CON MEDS = UNK| PREV MEDS = UNK