BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1873648 · Received October 13, 2010

    Report

    Report Number
    3003496686-2010-58517
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 12, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED ON 09/29/2010 FROM A DERMATOLOGIST VIA A COMPANY REP. A FEMALE PT EXPERIENCED NODULES AFTER INJECTIONS OF POLY-L-LACTIC ACID (SCULPTRA). THE PT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED TWO COURSES OF POLY-L-LACTIC ACID (SCULPTRA) INJECTIONS FOR NO REPORTED INDICATIONS. THE FIRST ONE WAS PERFORMED AROUND ON AN UNSPECIFIED DATE. THE SECOND ONE WAS PERFORMED (B)(6)2009. FOR THESE 2 COURSES POLY-L-LACTIC ACID (SCULPTRA) INJECTIONS, THE DOSES INJECTED AND BATCH NUMBERS WERE NOT REPORTED. THEN 18 MONTHS AFTER THE SECOND INJECTION, THE PT EXPERIENCED TWO NODULES NOS. DESPITE NOT TOTALLY CERTAIN INFORMATION, AN UNSPECIFIED CORRECTIVE TREATMENT WAS INITIATED. AT THE TIME OF THIS REPORT, THE NODULES PERSISTED. THE CASE HAD BEEN REGISTERED IN THE QUALITY ASSURANCE DATA BASE WITH THE PRODUCT TECHNICAL COMPLAINT (B)(4). FURTHER INFO HAD BEEN REQUESTED.

    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 Other| R PREV MEDS = UNK| CON MEDS = UNK