BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1903454 · Received November 15, 2010

    Report

    Report Number
    3003496686-2010-67490
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    November 15, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS UNSOLICITED REPORT FOR SCULPTRA (POLY-L-LACTIC ACID) WAS RECEIVED FROM A NURSE VIA A SALES REPRESENTATIVE TO OUR AFFILIATE IN (B)(4) ON (B)(6) 2010. ON GPE MEDICAL ASSESSMENT, PER INTERNAL IME DEFINITIONS AND THE SCULPTRA DECISION TREE, THIS CASE WAS UPGRADED TO SERIOUS. ALTHOUGH THE SOURCE DOCUMENT INDICATED A RUMOR CASE, PENDING FURTHER REQUESTED INFO, THE CASE IS NOT BEING CONSIDERED A RUMOR AT THIS TIME. THIS IS REPORT 1 OF 3, (B)(4). A PTC HAS BEEN INITIATED FOR THIS REPORT (PTC NUMBER PENDING). THIS REPORT INVOLVES A PT (DEMOGRAPHICS NOT PROVIDED) WHO WAS ADMINISTERED POLY-L-LACTIC ACID. DATES OF ADMINISTRATION, DOSAGE, LOT/BATCH NUMBER, LOCATION OF INJECTION/S AND INDICATION WERE NOT REPORTED. MEDICAL HISTORY WAS NOT INDICATED. CONCOMITANT MEDICATIONS WERE INDICATED AS UNK. A NURSE REPORTED THIS PT EXPERIENCED EDEMA AND RENAL FAILURE THREE WEEKS AFTER THE POLY-L-LACTIC ACID TREATMENT. NO OTHER DETAILS WERE PROVIDED. OUTCOME WAS NOT REPORTED. FURTHER INFO WILL BE REQUESTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED 10-NOV-2010: THIS PRELIMINARY REPORT DOES NOT YET INCLUDE ADEQUATE INFO TO ASSESS CAUSALITY. ADDITIONAL INFO REGARDING THE PT'S HISTORY, CONCOMITANT MEDICATIONS, LABORATORY VALUES, ETC HAS BEEN REQUESTED. THE EVENT OF RENAL FAILURE HAS NOT BEEN ASSOCIATED WITH SCULPTRA. THE EVENT OF EDEMA IN THE CONTEXT OF RENAL FAILURE IS ALSO CONSIDERED TO BE AN UNLISTED EVENT. PENDING FURTHER INFO, A CAUSALITY OF POSSIBLE HAS BEEN ASSIGNED TO BOTH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC UNK

    Patients

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