BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1971593 · Received January 20, 2011

    Report

    Report Number
    3003496686-2010-76420
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 11, 2010
    Report Date
    January 20, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM 18-JAN-2011: UPON SECOND MEDICAL EXAMINATION OF CASE AT TIME OF INTERNAL REVIEW THE FOLLOWING HAS BEEN MODIFIED IN THE CASE: EVENTS PAGE: LISTEDNESS FOR (B)(6) AMENDED FROM LISTED TO UNLISTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED 18-JAN-2011: (B)(6) IS AN UNLISTED EVENT FOR POLY-L-LACTIC ACID AND ASSOCIATED WITH EXISTING INFECTION WITH (B)(6). ALTHOUGH THIS PT IS NOTED NOT TO HAVE IMMUNOLOGICAL PROBLEMS, ADD'L INFO HAS BEEN REQUESTED REGARDING HER MEDICAL HISTORY. A CAUSALITY OF UNLIKELY IS ASSIGNED SINCE THE SHORT TIME TO ONSET (1 DAY) IS INCOMPATIBLE WITH THE INCUBATION PERIOD OF (B)(6) (2-3 WEEKS).

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS UNSOLICITED REPORT FOR SCULPTRA (POLY-L-LACTIC ACID) WAS REC'D FROM A HEALTH PROFESSIONAL VIA OUR AFFILIATE IN (B)(4). THIS REPORT INVOLVES A FEMALE, PT, (AGE NOT REPORTED) WHO WAS ADMINISTERED SCULPTRA ON (B)(6) 2010 (DOSAGES AND LOCATION OF INJECTION WERE NOT PROVIDED). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(4) 2010, A HEALTH PROFESSIONAL CONTACTED AN AFFILIATE REP TO REPORT A CLIENT HAD REC'D HER FIRST SCULPTRA TREATMENT ON (B)(6) 2010 AND EXPERIENCED A SKIN INFECTION AFTER INJECTION. NO FURTHER DETAILS WERE PROVIDED. ADD'L INFO WAS REC'D FROM THE PHYSICIAN ON (B)(6) 2011: UPON MEDICAL REVIEW, THE EVENT OF THIS CASE HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE (B)(4). F/U INFO FROM THE PHYSICIAN INDICATES THE PT WAS TREATED WITH POLY-L-LACTIC ON (B)(6) 2010 FOR COSMETIC PURPOSES. POLY-L-LACTIC ACID (DOSAGE NOT INDICATED) WAS RECONSTITUTED WITH 5 CC OF STERILE WATER. IT WAS INJECTED BY FANNING TECHNIQUE, DEPOT TECHNIQUE AND SUBCUTANEOUS INJECTION TO THE NASOLABIAL FOLDS, MARIONETTE LINES, TEMPLES AND CHEEK LINES. HYDRATION TIME WAS NOT INDICATED. ONE DAY AFTER THE INJECTIONS, THE PT EXPERIENCED A VIRAL INFECTION (HERPES ZOSTER) TO THE RIGHT SIDE OF THE FACE AND NOSE. THE LESION WAS 40 X 40 MM. THERE WAS NO EVIDENCE OF A SYSTEMIC PROCESS. NO BIOPSY WAS PERFORMED. THE PT WAS TREATED WITH UNSPECIFIED ORAL ANTIBIOTICS. NO SURGICAL INTERVENTION WAS REQUIRED. ON AN UNSPECIFIED DATE, THE PT RECOVERED. OUTCOME: RECOVERED. ACTION TAKEN: NOT APPLICABLE. RPTR'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 Other PREV MEDS =UNKNOWN| CON MEDS =UNKNOWN