BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCULPTRA

    MDR report key: 1112223 · Received August 7, 2008

    Report

    Report Number
    3002807108-2008-00025
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT: THIS SERIOUS SPONTANEOUS CASE FROM (B) (6) WAS REPORTED BY A PHYSICIAN VIA A CALL CENTER IN (B) (4), AND FORWARDED BY OUR (B) (4) (B) (4). THIS CASE INVOLVES A FEMALE PATIENT (AGE NOS) WHO RECEIVED AN APPLICATION OF POLY-L-LACTIC ACID (OBTAINED FROM GERMANY) ON AN UNKNOWN DATE IN 2008. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. SOMETIME IN 2008, THE PATIENT DEVELOPED HARDENING (NODULES) BENEATH HER EYES AFTER POLY-L-LACTIC ACID INJECTION INTO THE LOWER PALPEBRA AREA. CORRECTIVE TREATMENT WAS DESCRIBED AS SURGICAL INTERVENTION (NOS), WHICH REQUIRED HOSPITALIZATION. AT THE TIME OF THIS REPORT, THE EVENT REMAINS ONGOING. REPORTER'S CAUSALITY ASSESSMENT: UNKNOWN. ADDENDUM FOR FOLLOW-UP INFORMATION RECEIVED ON 31-JUL-08: THE PRODUCT WAS RECONSTITUTED WITH STERILIZED WATER ONLY. NO LIDOCAINE OR OTHER TOPIC ANESTHESIA WAS ADDED WHEN RECONSTITUTING THE PRODUCT WITH WATER. DILUTION WITH STERILIZED WATER WAS HIGH, AT LEAST 7-8 ML. THE TOTAL VOLUME INJECTED PER EYE AREA WAS LOW, LESS THAN 0.5ML PER SIDE OF FACE. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) HAS BEEN ISSUED. THIS CASE HAS BEEN PRE-REPORTED TO (B) (4) AUTHORITIES. (B) (4). MANUFACTURER'S PRELIMINARY COMMENTS: WITH THE INFORMATION PROVIDED BY THE REPORTER, THERE IS NO INDICATION OF A DEVICE DEFECT, MALFUNCTION, OR QUALITY ISSUE. NODULE IS CONSIDERED LISTED IN THE LABELING FOR THE PRODUCT. THE MANUFACTURE SEES NEITHER AN INCREASE 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

    (B) (4). INITIAL REPORT: THIS SERIOUS SPONTANEOUS CASE FROM (B) (6) WAS REPORTED BY A PHYSICIAN VIA A CALL CENTER IN (B) (4), AND FORWARDED BY OUR (B) (4) AFFILIATE (B) (4). THIS CASE IS THE FIRST OF 2 CASES REPORTED BY THE SAME REPORTER WITH THE SAME EVENTS. (B) (4). THIS CASE INVOLVES A FEMALE PATIENT (AGE NOS) WHO RECEIVED AN APPLICATION OF POLY-L-LACTIC ACID (OBTAINED FROM (B) (6)) ON AN UNKNOWN DATE IN 2008. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. SOMETIME IN 2008, THE PATIENT DEVELOPED HARDENING (NODULES) BENEATH HER EYES AFTER POLY-L-LACTIC ACID INJECTION INTO THE LOWER PALPEBRA AREA. CORRECTIVE TREATMENT WAS DESCRIBED AS SURGICAL INTERVENTION (NOS), WHICH REQUIRED HOSPITALIZATION. AT THE TIME OF THIS REPORT, THE EVENT REMAINS ONGOING. REPORTER'S CAUSALITY ASSESSMENT: UNKNOWN. ADDENDUM FOR FOLLOW-UP INFORMATION RECEIVED ON 31-JUL-08: THE PRODUCT WAS RECONSTITUTED WITH STERILIZED WATER ONLY. NO LIDOCAINE OR OTHER TOPIC ANESTHESIA WAS ADDED WHEN RECONSTITUTING THE PRODUCT WITH WATER. DILUTION WITH STERILIZED WATER WAS HIGH, AT LEAST 7-8 ML. THE TOTAL VOLUME INJECTED PER EYE AREA WAS LOW, LESS THAN 0.5ML PER SIDE OF FACE. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) HAS BEEN ISSUED. THIS CASE HAS BEEN PRE-REPORTED TO AUSTRIAN AUTHORITIES. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK