BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1882310 · Received October 22, 2010

    Report

    Report Number
    3003496686-2010-62688
    Event Type
    Injury
    Date Received
    October 22, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM AN OFFICE STAFF MEMBER ON BEHALF OF A PHYSICIAN ON (6)(6) 2010: A PATIENT OF AN UNSPECIFIED AGE AND GENDER WAS TREATED WITH POLY-L-LACTIC ACID [SCULPTRA]; LOT #, EXP DATE, THERAPY DATE AND INDICATION WERE NOT PROVIDED. THE REPORTER INITIALLY CONTACTED THE COMPANY REQUESTING FURTHER INFO ON PAPULES AND NODULES. SHE THEN STATED THE PT WAS TREATED WITH POLY-L-LACTIC ACID ON AN UNSPECIFIED DATE AND DEVELOPED A NODULE. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT PROVIDED. NO FURTHER RELEVANT INFO REPORTED.

    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