BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1556467 · Received December 8, 2009

    Report

    Report Number
    3003496686-2009-05062
    Date Received
    December 8, 2009
    Date of Event
    October 1, 2008
    Report Date
    November 26, 2009
    Manufacturer
    SANOFIAVENTIS U.S. LLC.
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    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 ON 26-NOV-09, BY A PHYSICIAN TO OUR LOCAL AFFILIATE (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE PT, WHO REC'D FOUR TREATMENTS OF POLY-L-LACTIC ACID THERAPY FOR FACE REJUVENATION. HER FIRST 3 TREATMENTS WERE GIVEN SOMETIME IN (B)(6) 2008, AND HER LAST TREATMENT WAS GIVEN IN (B)(6) 2009. NO OTHER TREATMENT DETAILS WERE PROVIDED. THE REPORTER MENTIONED THAT THE PT HAD NO PRECEDENT OF SKIN PROBLEMS NOR INFLAMMATION PROBLEMS. AFTER THE THIRD SESSION IN (B)(6) 2008, THE PT DEVELOPED A LITTLE GRANULOMA (SITE NOS). SOMETIME IN OC(B)(6) 2009, THE PT HAD SEVERAL GRANULOMAS IN BOTH CHEEKS. IT IS UNK IF ANY CORRECTIVE THERAPY WAS PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFO WERE NOT MENTIONED. OUTCOME - NOT RECOVERED. PHYSICIAN'S CAUSALITY ASSESSMENT: POSSIBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR PREV MEDS = UNK| CON MEDS = UNK