BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2161992 · Received May 12, 2011

    Report

    Report Number
    3003496686-2011-28461
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED ON (B)(6) 2011: THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A PHYSICIAN (DERMATOLOGIST) VIA A COMPANY REPRESENTATIVE AND INVOLVES A (B)(6) FEMALE. CONCOMITANT MEDICATION AND MEDICAL HISTORY WERE NOT REPORTED. ON (B)(6) 2010 THE FEMALE HAD BEEN TREATED WITH POLY-L-LACTIC ACID (SCULPTRA); APPLICATION SITE: AREA OF CHEEKS, NASOLABIAL AND SIDE OF CHIN. DOSAGE OF EACH APPLICATION: ONE BOTTLE OF POLY-L-LACTIC ACID DILUTED IN 7 ML WATER. SINCE (B)(6) 2011, THE FEMALE SUFFERED FROM 3-4 SUBCUTANEOUS, NON-VISIBLE BUT TACTILE IRRITATION-FREE NODULES IN THE AREA OF THE CHEEK (SIZE: 5-6 MM). ONE NODULE (LOCATED IN A (B)(6) SCAR) WAS SURGICALLY REMOVED. A HISTOLOGICAL IDENTIFICATION OF POLY-L-LACTIC ACID WAS POSITIVE. THE REMAINING NON-VISIBLE NODULES ARE CURRENTLY UNDER OBSERVATION, NO CORRECTIVE TREATMENT IS PLANNED SO FAR. OUTCOME: ONGOING AT THE TIME OF THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN