BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1658699 · Received April 12, 2010

    Report

    Report Number
    3003496686-2010-19561
    Event Type
    Injury
    Date Received
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    SANOFI AVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE QC PERFORMED ON 04/08/2010.

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS REPORTED BY A PHYSICIAN TO A SANOFI AVENTIS SALES REPRESENTATIVE ON (B) (6) 2010: A (B) (6) FEMALE CONSUMER RECEIVED AN INJECTION TRIAL OF POLY-L-LACTIC ACID (SCULPTRA, LOT# AND EXP DATE UNKNOWN) TO THE FACE ON AN UNKNOWN DATE. SHE DEVELOPED 3 MM AND ADJACENT 8 MM PAINFUL NODULES AT RIGHT PIRIFORM APERTURE, SUPERFICIAL TO THE BUCCAL MUCOSA FOUR DAYS LATER. IT WAS VERY PAINFUL TO THE PATIENT. IT WAS BROKEN UP WITH AN 18 GAUGE NEEDLE AND SHE RECEIVED TRIAMCINOLONE (KENALOG). AT THE TIME OF THE REPORT SHE WAS RECOVERING FROM THE EVENT. NO FURTHER RELEVANT INFORMATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R PREV MEDS = UNK| CON MEDS = UNK