BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2132147 · Received June 15, 2011

    Report

    Report Number
    3003496686-2011-37089
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 15, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2011: A (B)(6) YEAR-OLD FEMALE CONSUMER REPORTED THAT SHE RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNKNOWN, EXPIRATION DATE UNKNOWN) INJECTED ALL OVER HER CHEEK AREA, SIDE OF MOUTH AND TEMPLE IN (B)(6) OR (B)(6) 2011 ALONG WITH HYALURONIC ACID [JUVEDERM]. THE CONSUMER STATED SHE WAS DISSATISFIED WITH THE RESULTS. AFTER THE FIRST TREATMENT SHE SAW NOTHING. HER DOCTOR TOLD HER SHE NEEDED THREE TREATMENTS AND AFTER THE SECOND TREATMENT SHE WOULD SEE RESULTS BUT SHE HAS NOT SEEN ANY. AFTER HER SECOND TREATMENT AROUND EASTER, HER FACE WAS COMPLETELY SWOLLEN. IT TOOK THREE DAYS TO SETTLE DOWN. SHE HAD LOT OF BRUISING TOO AND LOOKED LIKE A CHIPMUNK. SHE HAD NOT SEEN THE RESULTS SHE EXPECTING. AT THE TIME OF THE REPORT, THE OUTCOME WAS ONGOING. NO FURTHER RELEVANT INFORMATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other CON MEDS = UNKNOWN