BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1971545 · Received January 20, 2011

    Report

    Report Number
    3003496686-2011-03222
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    January 20, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION OF INVESTIGATIONS IS PENDING.

    Description of Event or Problem · 1

    INITIAL REPORT REC'D ON (B)(6) 2011 FROM A PHYSICIAN FOR HERSELF VIA COMPANY REP. THIS FEMALE PHYSICIAN EXPERIENCED PAINFUL HARD INFLAMMATORY NODULES AND UNSPECIFIED TIMEFRAME AFTER THE INJECTION OF POLY-L-LACTIC ACID (SCULPTRA). THE PT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED TIME DATE, WHILE SHE WAS VOLUNTEERED FOR PARTICIPATION TO A POLY-L-LACTIC ACID SCULPTRA) WORKSHOP, SHE REC'D INJECTIONS OF POLY-L-LACTIC ACID (SCULPTRA) BATCH NUMBER UNSPECIFIED. THE SITES OF INJECTIONS WERE NOT REPORTED. NEVERTHELESS THE CONTEXT SUGGESTED THAT IT WAS IN THE CHEEKS BY SUBCUTANEOUS ROUTE. THEN, AN UNSPECIFIED TIME FRAME LATER, SHE PRESENTED WITH FIVE PAINFUL HARD INFLAMMATORY NODULES OF 2 MM OF DIAMETER, ON EACH CHEEK. SHE REC'D A CORRECTIVE TREATMENT WITH CORTISONE NOS AND OBSERVED AN IMPROVEMENT OF THE PAINFUL HARD INFLAMMATORY NODULES. DESPITE UNCLEAR INFO, IT SEEMED THAT AT THE DATE OF THE CONTACT THIS CORRECTIVE TREATMENT WAS ONGOING. NEVERTHELESS THE NODULES PERSISTED AT THE DATE OF THE CONTACT. THE CASE HAD BEEN REGISTERED IN THE SANOFI AVENTIS QUALITY ASSURANCE DATA BASE, UNDER THE PRODUCT TECHNICAL COMPLAINT NUMBER (B)(4).

    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