BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1550609 · Received December 2, 2009

    Report

    Report Number
    3003496686-2009-00974
    Event Type
    Injury
    Date Received
    December 2, 2009
    Report Date
    November 10, 2009
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT WAS REPORTED BY A NURSE VIA A COMPANY REPRESENTATIVE AND FORWARDED BY OUR LOCAL AFFILIATE. THIS CASE INVOLVES A FEMALE PATIENT WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY IN 2007 (2 VIALS), 2008 (2 VIALS), FOUR MONTHS LATER (1 VIAL), THREE MONTHS LATER (1 VIAL), AND 2009 (1 VIAL). NO ADDITIONAL TREATMENT DETAILS WERE PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED LUMPS ON HER CHEEKS. IT IS UNKNOWN IF ANY CORRECTIVE TREATMENT WAS GIVEN. EVENT'S OUTCOME IS UNKNOWN. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED.

    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 NA UNK

    Patients

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