BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1790039 · Received August 3, 2010

    Report

    Report Number
    3003496686-2010-44426
    Event Type
    Injury
    Date Received
    August 3, 2010
    Report Date
    August 3, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORTED FROM (B)(6) WAS REPORTED BY A PHYSICIAN ON 28-JUL-10 AND 29-JUL-10 VIA SALES REP - (B)(4). THIS NON-SERIOUS CASE WAS RECEIVED FROM A PHYSICIAN AND UPON MEDICAL REVIEW HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT (S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE. THIS CASE INVOLVES A FEMALE PT (AGE NOS) WHO HAD BEEN INJECTED WITH POLY-L-LACTIC ACID (SCULPTRA) ON AN UNSPECIFIED DATE (DOSAGE, INDICATION NOS) BY A PHYSICIAN DIFFERENT FROM THE REPORTER, AND NODULES WERE SHOWING SOME TIME LATER (NOT SPECIFIED). THESE NODULES WERE VISIBLE ONLY WITH CERTAIN GESTURES OF THE PT'S FACE. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. REPORTER CAUSALITY: NOT SPECIFIED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) HAS BEEN INITIATED. (B)(4).

    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 Other PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN