BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 1599998 · Received January 5, 2010

    Report

    Report Number
    3003496686-2009-10964
    Date Received
    January 5, 2010
    Report Date
    December 23, 2009
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE QC PERFORMED; 12/31/09 MON.

    Description of Event or Problem · 1

    INITIAL AND FOLLOW-UP INFO REC'D ON 23-DEC-2009 AND 28-DEC-2009 RESPECTIVELY, WERE PROCESSED TOGETHER. INITIAL REPORT: THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A PHYSICIAN VIA SALES REP TO OUR LOCAL AFFILIATE (B)(4). THIS CASE HAS BEEN DOWNGRADED TO NON-SERIOUS BY GPE. THIS CASE INVOLVES A FEMALE PT (AGE NOS) WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA), THERAPY DATES, DOSE, AND INDICATION NOS. ON AN UNSPECIFIED DATE, SHE EXPERIENCED NODULES. IT IS UNK IF THERE WAS ANY CORRECTIVE TREATMENT. NO OTHER INFO WAS PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. REPORTER'S CAUSALITY: POSSIBLE. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) HAS BEEN ISSUED. (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 CON MEDS = UNK| PREV MEDS = UNK