BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1882309 · Received October 22, 2010

    Report

    Report Number
    3003496686-2010-62664
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM A PHYSICIAN ON 12-OCT-2010: A (B)(6) FEMALE WAS TREATED WITH POLY-L-LACTIC ACID [SCULPTRA] (LOT #2A9033, EXP DATE: 30-SEP-2012) FOR AN UNSPECIFIED INDICATION IN THE CHEEK AND CHIN AREAS ON AN UNSPECIFIED DATE ABOUT 7 WEEKS AGO. THE PHYSICIAN INITIALLY CONTACTED THE COMPANY REQUESTING INFO ON THE DELAYED REACTION OF POLY-L-LACTIC ACID. HE THEN REPORTED THE PATIENT WAS SEEN 6 WEEKS AFTER THE INJECTIONS AND HAD GENERALIZED "SWELLING IN MAXILLARY AREAS" OF THE FACE. SHE WAS GIVEN ANTIBIOTICS NOS FOR A WEEK AND RETURNED TO THE OFFICE ON THE DAY OF THE REPORT. THE PHYSICIAN STATED THE SWELLING APPEARS TO BE GETTING WORSE AND "IS ON TOP OF THE SINUS AREA UNDER THE LOWER LIP NOW". 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 2A9033

    Patients

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