BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2132146 · Received June 15, 2011

    Report

    Report Number
    3003496686-2011-36837
    Event Type
    Injury
    Date Received
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS REC'D D FROM A SALES REP BY A NURSE ON (B)(6) 2011: AN ADULT MALE PT REC'D FOUR TREATMENTS OF POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNK, EXPIRATION DATE UNK) FOR AN UNK INDICATION. THE NURSE STATED THAT FOLLOWING THESE FOUR TREATMENTS, SHE HAD NOT SEEN ANY IMPROVEMENT IN THE PT'S FACIAL APPEARANCE. THE PT COULD HAVE POSSIBLY LOST SOME FACIAL VOLUME AT THIS POINT. THE NURSE WAS ASKING ON BEHALF OF THE PT FOR A REFUND. AT THE TIME OF THE REPORT, THE PT WAS NO LONGER RECEIVING POLY-L-LACTIC ACID AND THE REPORTED EVENT WAS ONGOING. NO FURTHER RELEVANT INFORMATION REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT ON (B)(6) 2011: THIS CASE REPORTED AN UNEXPECTED SIDE EFFECT OF FACIAL VOLUME LOSS AFTER LACK OF DRUG EFFECT WAS FOUND. IT IS NOT CLEAR IF THE FACIAL VOLUME LOSS WAS RELATED TO THE PT'S ONGOING UNDERLYING DISEASE. LACK OF DRUG EFFECT IS EXPECTED FOR SCULPTRA. ADDITIONAL INFORMATION IS NEEDED FOR FURTHER ASSESSMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CON MEDS: UNK| PREV MEDS: UNK