BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 3111940 · Received July 20, 2006

    Report

    Report Number
    3002807108-2006-00018
    Event Type
    Injury
    Date Received
    July 20, 2006
    Report Date
    May 31, 2006
    Manufacturer
    SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS BEING SUBMITTED VOLUNTARILY AS IT IS NOT CONSIDERED DEATH, LIFE THREATENING, OR PERMANENT INJURY NECESSITATING MEDICAL OR SURGICAL INTERVENTION. INITIAL REPORT: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA OUR AFFILIATE IN (B)(6). ALTHOUGH WE DO NOT HAVE YET THE INFORMATION ABOUT THE FACIAL SITES IN WHICH SCULPTRA WAS INJECTED, THE REPORTED EVENT IS MORE LIKELY DUE TO AN INJECTION IN THE FACE CLOSE TO NERVOUS RAMIFICATIONS OF THE FACIAL NERVE. THIS EVENT IS PROBABLY DUE TO "INJECTION TECHNIQUE" AND NOT CAUSED BY THE PRODUCT PER SE.

    Description of Event or Problem · 1

    AVENTIS CASE ID: (B)(4). INITIAL REPORT: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIAL OUR AFFILIATE IN (B)(6). THIS REPORT INVOLVES A FEMALE PATIENT WHO RECEIVED TREATMENT WITH SCULPTRA (POLY-L-LACTIC ACID) (DOSAGE, INDICATION AND THERAPY DATES NOT PROVIDED). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. A PHYSICIAN REPORTS THAT AFTER SCULPTRA WAS ADMINISTERED THIS PATIENT EXPERIENCED FACIAL PARALYSIS. THE PATIENT'S LIP HAS FALLEN IN ON ONE SIDE OF THE FACE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA INJECTABLE LMH SANOFI-AVENTIS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK