BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1741918 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00491
    Date Received
    December 21, 2009
    Date of Event
    February 1, 2007
    Report Date
    April 25, 2008
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO (NON SIGNIFICANT CHANGE) RECEIVED ON 05-JUN-2008: THE REPORTER DID NOT FILL THE PREGNANCY FORM DUE TO HE DID NOT RECEIVE ANY FURTHER INFO. ADDENDUM FOR F/U RECEIVED 05-SEP-2008. (B)(4): BATCH RECORD REVIEW WITHOUT HINT TO ROOT CAUSE. NO FAULTS, DEFECTS, DAMAGES DETECTABLE.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT: THIS SPONTANEOUS CASE INFO WAS RECEIVED FROM A SALES REP WHO HAD BEEN CONTACTED BY A PHYSICIAN AND CONCERNS A (B)(6) FEMALE. IN (B)(6) 2007, THE PATIENT HAD BEEN TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) INTO THE NASOLABIAL FOLD AND CORNER OF THE MOUTH. SHORT TIME LATER, SHE NOTICED NODULES, WHICH RESOLVED WITHIN THE NEXT MONTHS. NO PROBLEMS UNTIL (B)(6) 2008. ONE YEAR AFTER INJECTION OF POLY-L-LACTIC ACID (SCULPTRA), THE PT BECAME PREGNANT AND SINCE THEN SHE COMPLAINED ABOUT RECURRENCE OF NODULES AND SWELLING AT NASOLABIAL FOLD AND CORNER OF THE MOUTH. THESE FINDINGS WOULD CHANGE EVERY DAY. WHILE THE TREATING PHYSICIAN ASSESSED THE NODULES AS MILD, THE PATIENT DESCRIBED THEM AS "ESTHETICAL DISASTER." NO FURTHER INFO WAS RECEIVED SO FAR.

    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 38 YR