BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 2244008 · Received August 31, 2011

    Report

    Report Number
    3002807108-2011-54569
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 31, 2011
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT (B)(6) 2011: THERE IS A TEMPORAL RELATIONSHIP BETWEEN SCULPTRA INJECTION AND TRIGEMINAL NEURALGIA. AN INJECTION RELATED INJURY CANNOT BE RULED OUT. MRI RESULT WOULD PROVIDE A FURTHER INSIGHT INTO THE CAUSE. ADDITIONAL INFO ON THE OUTCOME OF THE EVENT AND MRI RESULT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    INITIAL INFO WAS RECEIVED FROM A PHYSICIAN (WHO IS ALSO PATIENT) ON (B)(6) 2011: AN ADULT FEMALE WITH NO SIGNIFICANT MEDICAL HISTORY RECEIVED HER FIRST AND ONLY SESSION WITH POLY-L-LACTIC ACID [SCULPTRA] LOT # AND EXPIRATION DATE NOT PROVIDED) FOR COSMETIC PURPOSES TO HER GLOBAL FACIAL AREA ON (B)(6) 2011. SHE STATED THE PROCEDURE WAS FLAWLESS AND IS EXTREMELY PLEASED WITH THE RESULTS. ON (B)(6) 2011 SHE HAD BEGUN TO EXPERIENCE SYMPTOMS OF TRIGEMINAL NEURALGIA IN HER FACIAL REGION. ON (B)(6) 2011, SHE SAW A NEUROLOGIST WHO CONFIRMED THE DIAGNOSES OF TRIGEMINAL NEURALGIA AND WAS IMMEDIATELY STARTED ON TREATMENT WITH ORAL DOSES OF OXCARBAZEPINE [TRILEPTAL]. TREATMENT WITH OXCARBAZEPINE CONTINUES AT THE TIME OF THIS REPORT AND SHE CONSIDERS THE EVENT OF TRIGEMINAL NEURALGIA AS RECOVERING. SHE IS UNSURE IF SHE CONSIDERS POLY-L-LACTIC ACID SUSPECT IN THE EVENT OF TRIGEMINAL NEURALGIA. THE NEUROLOGIST HAD SCHEDULED A MAGNETIC RESONANCE IMAGING SCAN [MRI] FOR (B)(6) 2011 TO RULE OUT ANY OTHER ANOMALY. NO FURTHER RELEVANT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CON MEDS =UNKNOWN| PREV MEDS =UNKNOWN