BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1790002 · Received August 2, 2010

    Report

    Report Number
    3003496686-2010-43503
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    SANOFI-AVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 30-JUL-10, DEVICE QC PERFORMED.

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN VIA A COMPANY REPRESENTATIVE. A FEMALE PT EXPERIENCED SWELLING AND INDURATION ON NASOLABIAL FOLDS 14 MONTHS AFTER THE THIRD INJECTION OF POLY-L-LACTIC ACID (SCULPTRA). PRIOR TO THESE SYMPTOMS, SHE PRESENTED WITH AN INFECTIOUS EPISODE OF RHINITIS. CORTICOID CREAM WAS PRESCRIBED. AT TIME OF REPORTING, ACTION TAKEN AND OUTCOME WERE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFI-AVENTIS U.S. LLC UNK

    Patients

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