BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1802609 · Received August 12, 2010

    Report

    Report Number
    3003496686-2010-45814
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 12, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A GENERAL PRACTITIONER 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). INITIAL AND FOLLOW-UP RECEIVED ON 04-AUG AND 05-AUG-10 RESPECTIVELY WERE PROCESSED TOGETHER. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO DEVELOPED APPROXIMATELY 4-5 NODULES AROUND THE MARIONETTE AREA WHICH WERE NOTICED IN THE LAST 2-3 MONTHS ((B)(6) 2010). THE PATIENT RECEIVED AN INJECTION OF POLY-L-LACTIC ACID (SCULPTRA) THERAPY (2 VIALS) ON (B)(6) 2008 (LOT NUMBER A7023). THE NODULES ARE NOT VISIBLE, BUT THEY ARE PALPABLE, HARD AND MOBILE. POLY-L-LACTIC ACID WAS ADMINISTERED IN THE MARIONETTE AREA. RELEVANT MEDICAL HISTORY INCLUDES (B)(6), WHICH IS UNDER CONTROL. THE PATIENT IS NOT ON ANY CONCOMITANT MEDICATION. ACTION TAKEN/CORRECTIVE TREATMENT: UNKNOWN. OUTCOME: NOT RECOVERED/NOT RESOLVED. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) HAS BEEN INITIATED, CONCLUSION PENDING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) INSULIN DELIVERY LMH SANOFIAVENTIS U.S. LLC A7023

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other CON MEDS = NONE| PREV MEDS = UNKNOWN