BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 830687 · Received March 13, 2007

    Report

    Report Number
    3002807108-2007-00002
    Event Type
    Other
    Date Received
    March 13, 2007
    Report Date
    February 23, 2007
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED FROM A PHYSICIAN ON 2/23/07: THIS SPONTANEOUS CASE INVOLVES A FEMALE PT WHO RECEIVED ONE TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) IN 2006; PT DEMOGRAPHICS, DOSAGE, AND INDICATION WERE NOT PROVIDED. THE PT ALSO RECEIVED TREATMENT WITH BOTULINUM TOXIN TYPE A (BOTOX) ON AN UNSPECIFIED DATE. IT IS UNCLEAR IF THE PT RECEIVED BOTULINUM TOXIN TYPE A AT THE SAME TIME AS POLY-L-LACTIC ACID. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PHYSICIAN INJECTED POLY-L-LACTIC ACID IN THE CHEEKS, LOWER EYELIDS, AND NASAL LABIAL FOLDS. THE PHYSICIAN REPORTS THAT THE PT IS CLAIMING THAT SHE IS NOW "DISFIGURED" AFTER TREATMENT WITH POLY-L-LACTIC ACID AND BOTULINUM TOXIN TYPE A. THE PHYSICIAN STATES HE HAS NOT SEEN OR EXAMINED THE PT SINCE HER CLAIM OF BEING "DISFIGURED." NO FURTHER MEDICAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA INJECTABLE LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR