BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1733896 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00818
    Date Received
    December 21, 2009
    Date of Event
    April 25, 2009
    Report Date
    April 27, 2009
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: GLOBAL PTC NUMBER (B)(4). ADDENDUM FOR F/U INFO RECEIVED ON (B)(6) 2009: PTC RESULTS FOR BATCH A8025 REVEALED: BRR (BATCH RECORD REVIEW) WITHOUT HINT TO ROOT CAUSE. NO FAULTS, DEFECTS, DAMAGES DETECTABLE. THE REVIEW OF THE DHR (DEVICE HISTORY RECORDS) AND OF THE ANALYTICAL RESULTS OF THE INVOLVED BATCH DIDN'T' SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT ISN'T BATCH RELATED. CONCLUSION: NO FAULTS DETECTABLE.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS REPORTED BY A PHYSICIAN THROUGH THE COMPANY OTC BRAND MANAGER AND FORWARDED BY OUR LOCAL AFFILIATE ((B)(4)). THIS CASE INVOLVES A FEMALE PT (AGE NOS) WHO RECEIVED HER FIRST TREATMENT OF POLY-L-LACTIC ACID (SCULPTRA) THERAPY ON (B)(6) 2009. LIDOCAINE, A DISINFECTANT (NOS), AND AVENE SKIN RECOVERY CREAM WERE USED DURING THIS TREATMENT, BUT WERE NOT SUSPECTED. ADD'L CONCOMITANT MEDICATIONS AND RELEVANT MEDICAL HISTORY WERE NOT MENTIONED. ON (B)(6) 2009, THE PT EXPERIENCED REDNESS, SWELLING, AND SEVERE ITCHING OF THE FACE. CORRECTIVE TREATMENT BY THE DERMATOLOGIST INCLUDED CORTISONE INJECTIONS AND AN ORAL ANTIHISTAMINE. THE PT RECOVERED FROM THIS EVENT ON (B)(6) 2009. THE REPORTER SUSPECTED THAT THE EVENT WAS RELATED TO POLY-L-LACTIC ACID THERAPY, BUT ALSO ASKED THE PT TO CHANGE THE CREAM THAT SHE HAD USED FOR SKIN MASSAGE TO ANOTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA WRINKLE FILLER LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA A8025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK