BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1882343 · Received October 22, 2010

    Report

    Report Number
    3003496686-2010-62799
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 3, 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
    AS
    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 (B)(6) 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 (LOCAL REFERENCE (B)(4)). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) IN (B)(6) 2008 AND AGAIN IN (B)(6) 2008 FOR AN UNSPECIFIED INDICATION. DILUENTS USED WERE 5ML STERILE WATER AND 1ML 2% XYLOCAINE. THE SITES OF INJECTION WERE HOLLOW CHEEKS, NASOGENIAL FURROWS, NASOLABIAL FOLDS, AND JAW LINE. THE PRODUCT LOT NUMBERS WERE A7018 FOR BOTH TREATMENTS. THE PHYSICIAN REPORTED THAT HE HAD NOTICED SPLIT-PEA-SIZED LUMPS AROUND (B)(6) 2010 THAT WAS 2 YEARS AFTER THE TREATMENT. THE PHYSICIAN ALSO NOTICED THAT THE PATIENT DEVELOPED NUMEROUS SMALL PALPABLE NODULES IN DISTRIBUTION OF POLY-L-LACTIC ACID INJECTIONS SITES I.E. CHEEKS AND ALONG THE JAW LINE ON (B)(6) 2010. THE PATIENT WAS TREATED WITH DOXYCYCLINE FOR 6 WEEKS. IT WAS REPORTED THAT THE PATIENT WAS FIT AND WELL WITH NO HISTORY OF ALLERGY AND ADVERSE RESPONSE TO OTHER DRUGS. THE OUTCOME WAS REPORTED AS MINIMAL CHANGE IN THE NODULES. SIGNIFICANT/RELEVANT MEDICAL HISTORY: NOT REPORTED. RELEVANT CONCOMITANT MEDICATIONS: NONE. ACTION TAKEN: NOT APPLICABLE. OUTCOME - NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFI AVENTIS U.S. LLC A7018

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R PREV MEDS = UNKNOWN| CON MEDS = NONE