BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 1373603 · Received April 30, 2009

    Report

    Report Number
    3002807108-2009-00015
    Event Type
    Other
    Date Received
    April 30, 2009
    Date of Event
    July 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A PHYSICIAN VIA A QUESTIONNAIRE TO A SALES REPRESENTATIVE. IT INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TWO TREATMENTS OF POLY-L-LACTIC ACID (SCULPTRA). SHE RECEIVED HER FIRST SESSION ON (B)(6) 2007 AND THE SECOND SESSION ON (B)(6) 2007 REGION INJECTED: NASOGENAL FURROWS, NASOLABIAL FOLDS. IN (B)(6) 2008, THE PATIENT DEVELOPED LATE GRANULOMAS (TO STRANGE OBJECT) ON THE NASOGENAL FURROWS AREA AND BEYOND THE NASOLABIAL FOLDS, AND LIGHT SKIN COLORATION. TRIAMCINOLONE WAS PRESCRIBED AS CORRECTIVE TREATMENT FOR THIS EVENT, AND POLY-L-LACTIC ACID THERAPY WAS DISCONTINUED. THE PATIENT HAS NOT HAD ANY PREVIOUS SIMILAR EVENTS AFTER TREATMENT WITH OTHER PRODUCTS. NO HISTOLOGY OR OTHER LABORATORY TESTS WERE PERFORMED. AT THE TIME OF THIS REPORT, THE EVENT REMAINS ONGOING. REPORTER'S CAUSALITY ASSESSMENT: POSSIBLE. ADDENDUM FOR FOLLOW-UP INFORMATION RECEIVED ON 21-APR (REPORTED BY THE PHYSICIAN VIA A SALES REPRESENTATIVE) AND 22-APR-09 (REPORTED BY THE PHYSICIAN VIA A DERMIK MEDICAL ADVISOR) RESPECTIVELY WERE PROCESSED TOGETHER, AND BASED UPON THIS NEW INFORMATION, THIS CASE INITIALLY ASSESSED AS NON-SERIOUS, HAS BEEN UPGRADED TO SERIOUS MEDICALLY IMPORTANT. THE EVENT TERM WAS CHANGED TO SUBCUTANEOUS INDURATED PAINFUL AREA "NEARLY" THE SIZE OF AN ALMOND. AFTER INJECTING TRIAMCINOLONE TWO OR THREE TIMES, THE PATIENT IMPROVED FOR SOME DAYS, HOWEVER, WORSENED LATER. THE PHYSICIAN DECIDED THAT THE PATIENT WAS TO START ANTIBIOTIC THERAPY, BUT IT HAD NOT YET BEEN STATED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A PHYSICIAN VIA A QUESTIONNAIRE TO A SALES REPRESENTATIVE, A FORWARDED BY TO OUR LOCAL AFFILIATE (B)4). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TWO TREATMENTS OF POLY-L-LACTIC ACID (SCULPTURAL). SHE RECEIVED HER FIRST SESSION ON (B)(6) 2007 (DILUTION VOLUME: STERILE WATER, 5 ML/AMOUNT INJECTED; 5 ML/ BATCH NUMBER 1A7201/REGION INJECTED: BOTH LOWER NASOGENAL FURROWS) AND THE SECOND SESSION ON (B)(6) 2007 (DILUTION VOLUME: STERILE WATER, 5 ML/AMOUNT INJECTED: 5 ML/BATCH NUMBER 1A7201/REGION INJECTED: NASOGENAL FURROWS, NASOLABIAL FOLDS). IN (B)(6) 2008, THE PATIENT DEVELOPED LATE GRANULOMAS (TO STRANGE OBJECT) ON THE NASOGENAL FURROWS AREA AND BEYOND THE NASOLABIAL FOLDS, AND LIGHT SKIN COLORATION. TRIAMCINOLONE WAS PRESCRIBED AS CORRECTIVE TREATMENT FOR THIS EVENT, AND POLY-L-LACTIC ACID THERAPY WAS DISCONTINUED. THE PATIENT HAS NOT HAD ANY PREVIOUS SIMILAR EVENTS AFTER TREATMENT WITH OTHER PRODUCTS. NO HISTOLOGY OR OTHER LABORATORY TESTS WERE PERFORMED. AT THE TIME OF THIS REPORT, THE EVENT REMAINS ONGOING. REPORTER'S CAUSALITY ASSESSMENT: POSSIBLE. ADDENDUM FOR FOLLOW-UP INFORMATION RECEIVED ON 21-APR (REPORTED BY THE PHYSICIAN VIA A SALES REPRESENTATIVE) AND 22-APR-09 (REPORTED BY THE PHYSICIAN VIA A DERMIK MEDICAL ADVISOR) RESPECTIVELY WERE PROCESSED TOGETHER, AND BASED UPON THIS NEW INFORMATION, THIS CASE INITIALLY ASSESSED AS NON-SERIOUS, HAS BEEN UPGRADED TO SERIOUS MEDICALLY IMPORTANT. THE EVENT TERM WAS CHANGED TO SUBCUTANEOUS INDURATED PAINFUL AREA "NEARLY" THE SIZE OF AN ALMOND. AFTER INJECTING TRIAMCINOLONE TWO OR THREE TIMES, THE PATIENT IMPROVED FOR SOME DAYS, HOWEVER, WORSENED LATER. THE PHYSICIAN DECIDED THAT THE PATIENT WAS TO START ANTIBIOTIC THERAPY, BUT IT HAD NOT YET BEEN STARTED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA WRINKLE FILLER LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA 1A7201

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR