BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1882308 · Received October 22, 2010

    Report

    Report Number
    3003496686-2010-62755
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 21, 2010
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO WAS REPORTED BY A PHYSICIAN TO A SANOFI AVENTIS SALES REP ON (6)(6) 2010 AND ADD'L INFO WAS RECEIVED FROM THE PHYSICIAN ON (6)(6) 2010: A MALE PT RECEIVED TREATMENT WITH POLY-L-LACTIC ACID [SCULPTRA AESTHETIC] (LOT # UNK, EXP DATE: UNK) FOR COSMETIC REASONS SOMETIME THIS YEAR (2010) AND EXPERIENCED PAPULES THAT WERE SPREAD OUT IN THE PERIORBITAL REGION WHERE HE RECEIVED THE INJECTIONS. HE GAVE HIM TRIAMCINOLONE (KENALOG) INJECTIONS AND INJECTIONS OF WATER AS TREATMENT. NO FURTHER RELEVANT INFO REPORTED. THIS CASE IS ASSOCIATED WITH (6)(4) (SAME REPORTER).

    Devices

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

    Patients

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