BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1822870 · Received August 31, 2010

    Report

    Report Number
    3003496686-2010-50724
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2009
    Report Date
    August 31, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS RECEIVED FROM A PHYSICIAN ON (B)(6), 2010 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 ((B)(4)). THIS CASE INVOLVES AN ADULT FEMALE PATIENT WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY IN (B)(6) 2009. ONE VIAL WAS INJECTED. NO ADDITIONAL TREATMENT DETAILS WERE MENTIONED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. ONE MONTH AFTER POLY-L-LACTIC ACID THERAPY, THE PATIENT DEVELOPED NODULES IN THE NASOLABIAL FOLDS AND MARIONETTE LINES. CORRECTIVE THERAPY WAS PROVIDED WHICH INCLUDED RADIO-FREQUENCY. OUTCOME - UNKNOWN. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: LOCAL PTC NUMBER (B)(4); GLOBAL PTC NUMBER (B)(4). PHYSICIAN'S CAUSALITY ASSESSMENT: NOT SPECIFIED.

    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 PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN