BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1843448 · Received September 22, 2010

    Report

    Report Number
    3003496686-2010-54891
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 22, 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 13-SEP-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 A (B)(6) FEMALE PATIENT WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY IN (B)(6)-2010 AND (B)(6)-2010. NO ADDITIONAL TREATMENT DETAILS WERE REPORTED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INDURATION AND SWELLING IN THE TREATED AREAS. OUTCOME REPORTED AS ONGOING. NO OTHER INFORMATION WAS PROVIDED. ACTION TAKEN/CORRECTIVE TREATMENT - UNKNOWN. OUTCOME - NOT RECOVERED/NOT RESOLVED. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: (B)(4). PHYSICIAN'S CAUSALITY ASSESSMENT: NOT PROVIDED.

    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 58 YR Other PREV MEDS = UNK| CON MEDS = UNK