BEUDAMED
    FDA Adverse Event Summary report: N

    POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)

    MDR report key: 1892872 · Received November 4, 2010

    Report

    Report Number
    3003496686-2010-66563
    Date Received
    November 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS REPORTED BY A CONSUMER ON 29-OCT-10. LOCAL REFERENCE (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE PT WHO WAS INJECTED WITH POLY-L-LACTIC ACID (SCULPTRA) 2 VIALS, 1 MONTH AGO (NOS). INJECTED AREAS: CHEEKS, NECK, NASOGENIAN FOLDS AND OTHER REGIONS OF HER FACE (NOS). SINCE THEN, THE PT HAD BEEN EXPERIENCING ITCHING AND BURNING IN HER FACE, BACK OF THE NECK AND SOMETIMES, ALL OVER THE BODY. RELEVANT MEDICAL HISTORY INCLUDES PREVIOUS TREATMENT WITH HYALURONIC ACID IN CHEEKBONES 2 YEARS AGO. CONCOMITANT TREATMENT: HYDRATANT CREAM AND SUN LOTION GIVEN BY THE PHYSICIAN. ACCORDING TO THE PT, HER PHYSICIAN RULED OUT POLY-L-LACTIC ACID AS ETIOLOGY OF THE EVENT. SHE WAS SATISFIED WITH THE RESULTS AND A NEW SESSION WAS SCHEDULED FOR (B)(6) 2010. EVENT OUTCOME: RECOVERING. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) HAS BEEN INITIATED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR HYALURONIC ACID (PREV.)| ALL OTHER THERAPEUTIC PRODUCTS (CON.)