BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 2243982 · Received August 31, 2011

    Report

    Report Number
    3002807108-2011-55206
    Date Received
    August 31, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: (B)(4) COMPANY COMMENT (B)(4) 2011: THIS FEMALE PT WITH AN UNK MEDICAL HISTORY DEVELOPED CUTANEOUS SARCOIDOSIS, MENINGITIS, AND PAPULE AFTER RECEIVING SCULPTRA INJECTION. IT IS UNCLEAR THE ONSET DATE OF THESE EVENTS IN RELATION TO THE TREATMENT SCHEDULE. THERE IS NO BIOPSY TO CONFIRM THE DIAGNOSES. ADD'L INFO IS NEEDED FOR A FURTHER MEDICAL EVAL.

    Description of Event or Problem · 1

    INITIAL INFO WAS RECEIVED BY A SALES REP FROM A PHYSICIAN ON (B)(6) 2011: A PT RECEIVED INJECTABLE POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNK, EXP DATE UNK) AND EXPERIENCED A BUNCH OF PAPULES IN THE CHEEK AREA. THEY WERE TOUCHABLE AND THE SKIN LOOKED BUMPY. THE PHYSICIAN FELT THAT THE PRODUCT "WORKED TOO WELL". THE PT WAS DIAGNOSED WITH CUTANEOUS SARCOIDOSIS. THIS PT ALSO HAD MENINGITIS IN 2010, BUT THE PHYSICIAN WAS NOT SURE IF THIS WAS RELATED TO THE POLY-L-LACTIC ACID. THE PT HAS NOT FULLY RECOVERED FROM THE CUTANEOUS SARCOIDOSIS. IT IS UNK IF THE PT HAS RECOVERED FROM THE MENINGITIS. NO FURTHER RELEVANT INFO REPORTED.

    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 PREV MEDS| CON MEDS