BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)

    MDR report key: 2095280 · Received May 10, 2011

    Report

    Report Number
    3003496686-2011-26268
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    May 10, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT HAS BEEN UPGRADED TO SEROUS, MEDICALLY IMPORTANT BASED TO THE INFO REC'D ON (B)(6) 2011. THIS NON-SERIOUS UNSOLICITED REPORT WAS REC'D FROM A COMPANY SALES REP VIA OUR LOCAL AFFILIATE (B)(4) ON (B)(6) 2011 (TWO CONTACTS UNIFIED INTO ONE REPORT BY THE AFFILIATE). IT HAS BEEN CONFIRMED THAT THIS CASE INVOLVES A (B)(6) FEMALE, WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA), ONE VIAL RECONSTITUTED WITH 8 ML OF STERILE WATER PLUS LOCAL ANESTHETIC, ON (B)(6) 2009, AND 2 TWO VIALS ON (B)(6) 2009 (INDICATION, LOCATION OF INJECTIONS AND BATCH/EXP. DATE UNK). THIS PT NOTICED FOUR GRANULOMAS AROUND (B)(6) 2010, ONE WAS THE SIZE OF A PEA. THE OTHERS WERE SMALLER AND ONLY SLIGHTLY VISIBLE. THEY HAVE CONTINUED TO INCREASE IN SIZE AND THEY WERE CONFIRMED TO BE GRANULOMAS (FOREIGN BODY) BY A BIOPSY. CORRECTIVE TREATMENT INCLUDED INJECTABLE STEROIDS INTO THE AREAS THAT WERE AFFECTED AND THE PT WAS TO BE REVIEWED IN THE NEAR FUTURE. THE EVENT WAS ONGOING AT THE TIME OF THIS REPORT. SIGNIFICANT/RELEVANT MED HISTORY INCLUDED MELANOMA. RELEVANT CONCOMITANT MEDICATIONS - NOT REPORTED. ACTION TAKEN UNK. CORRECTIVE TREATMENT - STEROID INJECTIONS. OUTCOME - NOT RECOVERED/NOT RESOLVED. THE LOCAL QUALITY DEPT HAS INITIATED A PTC (PRODUCT TECHNICAL COMPLAINT) FOR THIS REPORT: (B)(4). ADD'L INFO WAS REC'D FROM THE SALES REP ON (B)(6) 2011 (UNIFIED ONE REPORT), AND FURTHER INFO WAS REC'D FROM A PHYSICIAN ON (B)(6) 2011. SCULPTRA THERAPY DATES, EVENT ONSET DATE, MED HISTORY AND PT DEMOGRAPHICS WERE AMENDED. CORRECTIVE TREATMENT OF STEROID INJECTIONS WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other ANAESTHETICS| LOCAL (CON.)| PREV MEDS - UNK