BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 843946 · Received April 18, 2007

    Report

    Report Number
    3002807108-2007-00008
    Event Type
    Other
    Date Received
    April 18, 2007
    Report Date
    March 22, 2007
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INFO RECEIVED ON 22-MAR-2007 FROM A PHYSICIAN: THIS SPONTANEOUS REPORT INVOLVED A FEMALE CONSUMER WHO INITIATED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) FOR COSMETIC PURPOSES IN 2005 AND RECEIVED A TOTAL OF 3 VIALS "OVER TIME" (OTHER THERAPY DATES UNKNOWN). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, THE CONSUMER DEVELOPED NODULES, UNDER THE SKIN BY THE LOWER LID, ABOVE THE CHEEK. THE NODULES ARE ONGOING AT THE TIME OF REPORT AND THE CONSUMER IS SEEKING TO HAVE THE NODULES SURGICALLY REMOVED BY A PLASTIC SURGEON. NO LOT NUMBERS OR EXPIRATION DATES WERE REPORTED. NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. NODULE IS CONSIDERED LISTED IN THE LABELING FOR THE PRODUCT. THE MANUFACTURE SEES NEITHER AN INCREASED TREND IN FREQUENCY OR SEVERITY OF NODULE, NOR ANY NEW SAFETY SIGNALS AS THE RESULT OF THIS REPORT. NODULE IS TYPICALLY A COSMETIC CONCERN AND NOT A MAJOR MEDICAL ISSUE THAT WOULD RESULT IN PERMANENT DISABILITY, A LIFE-THREATENING CONDITION, OR FATAL INJURY. THIS REPORT IS BEING SUBMITTED TO MAINTAIN CONSISTENCY IN ADVERSE EVENT REPORTING ACROSS REGIONS.

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED ON 22-MAR-2007 FROM A PHYSICIAN: THIS SPONTANEOUS REPORT INVOLVES A FEMALE CONSUMER WHO INITIATED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) FOR COSMETIC PURPOSES IN 2005, AND RECEIVED A TOAL OF 3 VIALS " OVER TIME" (OTHER THERAPY DATES UNKNOWN). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, THE CONSUMER DEVELOPED NODULES, UNDER THE SKIN BY THE LOWER LID, ABOVE THE CHEEK. THE NODULES ARE ONGOING AT THE TIME OF REPORT AND THE CONSUMER IS SEEKING TO HAVE THE NODULES SURGICALLY REMOVED BY A PLASTIC SURGEON. NO LOT NUMBERS OR EXPIRATION DATES WERE REPORTED. NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR