BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1882342 · Received October 22, 2010

    Report

    Report Number
    3003496686-2010-63507
    Event Type
    Injury
    Date Received
    October 22, 2010
    Report Date
    October 21, 2010
    Manufacturer
    SANOFI AVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS RECEIVED FROM A PHYSICIAN ON 15-OCT-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 FEMALE PT WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY SOMETIME IN (B)(6) 2010. NO ADD'L TREATMENT DETAILS WERE MENTIONED. SOMETIMES AFTER HER SECOND TREATMENT, THE PT DEVELOPED PAPULES ON HER NECK. NO OTHER INFO WAS PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFO WERE NOT REPORTED. ACTION TAKEN/CORRECTIVE TREATMENT/OUTCOME - UNK. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED. (B)(4) . PHYSICIAN'S CAUSALITY: NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-L-LACTIC ACID (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFI AVENTIS U.S. LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN