BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1890034 · Received November 2, 2010

    Report

    Report Number
    3003496686-2010-65881
    Event Type
    Injury
    Date Received
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM A NURSE ON (B)(6) 2010: A NURSE REPORTED FEMALE PTS EXPERIENCED A GRANULOMA AFTER INJECTIONS WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT # AND EXP DATE UNK). NO CONCOMITANT MEDICATIONS OR MEDICAL HISTORY REPORTED. NO FURTHER INFO REPORTED.

    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