BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1741843 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00636
    Date Received
    December 21, 2009
    Date of Event
    July 26, 2008
    Report Date
    September 8, 2008
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER'S CAUSALITY ASSESSMENT: NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED ON OCT-2-2008: A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) HAS BEEN RECEIVED (B)(4). BRR (BATCH RECORD REVIEW) WITHOUT HINT TO ROOT CAUSE. NO FAULTS, DEFECTS, DAMAGES DETECTABLE. THE REVIEW OF THE DHR (DEVICE HISTORY REPORT) AND OF THE ANALYTICAL RESULTS OF THE INVOLVED BATCH DID NOT SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT THAT OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE.

    Description of Event or Problem · 1

    AVENTIS CASE ID: (B)(4). INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER TO OUR LOCAL AFFILIATE (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED A TREATMENT OF POLY-L-LACTIC ACID (SCULPTRA) ON (B)(6) 2008 AS A FILLER FOR HER FACIAL LINES. RELEVANT MEDICAL HISTORY WAS NOT MENTIONED, AND CONCOMITANT MEDICATION WAS REPORTED AS A NATURAL PARASITE CLEANSER WHICH SHE DISCONTINUED ON (B)(6) 2008. THE PATIENT REPORTED THAT FOLLOWING HER TREATMENT, SHE MASSAGED HER FACE AS DIRECTED (FIVE MINUTES PER SITE AT LEAST FIVE TIMES DAILY. THE DAY AFTER HER TREATMENT, SHE NOTICED CYSTS IN HER FACE. SHE FOUND THREE BY HER SMILE LINE AND OTHERS AT VARIOUS LOCATIONS, TOTALING 11. SHE REPORTED THAT ONE CYST ON HER CHIN LOOKED LIKE THERE WAS FLUID IN IT, AND IT KEPT COMING BACK. SHE REPORTS THAT THE CYSTS HAVE BEEN COMING AND GOING OVER THE LAST SIX WEEKS, AND THAT THERE WERE RED SPOTS APPEARING AFTER THE CYSTS WENT AWAY, WHICH SHE HAS TREATED BY LASER. SHE SAW A DERMATOLOGIST WHO SUGGESTED TREATMENT WITH ISOTRETINOIN (ACCUTANE), BUT SHE DID NOT TAKE THIS. AT THE TIME OF THIS REPORT, THE EVENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA WRINKLE FILLER LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR