BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1873651 · Received October 13, 2010

    Report

    Report Number
    3003496686-2010-60546
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM A PHYSICIAN ON (B)(6) 2010: IT WAS REPORTED THAT A FEMALE PT RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT# AND EXP DATE UNK OR NEW FILL) APPROX 3-4 YRS AGO. PT WAS RE-INJECTED WITH ONE VIAL OF POLY-L-LACTIC ACID DILUTED TO 8CC IN (B)(6) OF 2009, AND AGAIN WITH ONE VIAL OF POLY-L-LACTIC ACID DILUTED TO 9CC IN (B)(6) OF 2010. PT NOW HAS SEVERAL VISIBLE NODULES IN THE CHEEK AREA. NO CONCOMITANT MEDICATIONS OR MEDICAL HISTORY REPORTED. NO FURTHER INFO REPORTED.

    Devices

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

    Patients

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