BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2212911 · Received August 10, 2011

    Report

    Report Number
    3002807108-2011-49763
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    August 10, 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
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED ON 04-AUG-2011 BY A PHYSICIAN - LOCAL REFERENCE (B)(4). THIS CASE INVOLVES A FEMALE, PT, OF UNK AGE, WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) (INDICATION, THERAPY DATES, LOCATION OF INJECTIONS, BATCH AND EXPIRATION DATE ARE UNK). A PHYSICIAN REPORTS A FEMALE, PT, WAS TREATED WITH POLY-L-LACTIC ACID AND EXPERIENCED FACIAL PARALYSIS ONE WEEK AFTER THE INJECTIONS. THE PT AND HER GENERAL PRACTITIONER ASSESS A CAUSAL RELATIONSHIP BETWEEN THE TREATMENT WITH POLY-L-LACTIC ACID AND THE FACIAL PARALYSIS. THE FACIAL PARALYSIS IS ON THE DECLINE. THE REPORTER DESCRIBES THE PT AS PSYCHIC CONSPICUOUS AND THINKS SHE FORMS HER OWN THEORIES. SIGNIFICANT MEDICAL HISTORY AND RELEVANT CONCOMITANT MEDICATIONS WERE NOT REPORTED. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: UNK. OUTCOME: RECOVERING / RESOLVING. A PTC (PRODUCT TECHNICAL COMPLAINT) HAS BEEN INITIATED FOR THIS REPORT. (B)(4). PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED 4-AUG-2011: THIS PT DEVELOPED FACIAL PARALYSIS ONE WEEK AFTER INJECTION WITH POLY-L-LACTIC ACID. THE REPORT LACKS THE INFO ON SCULPTRA ADMINISTRATION DATES, DOSAGES, HYDRATION TIME, TECHNIC, MEDICAL HISTORY, CONCOMITANT DRUGS, CORRECTIVE TREATMENT, PTC REPORT AND NEUROLOGY CONSULT FOR COMPLETE ASSESSMENT. AS PER THE REPORTER THIS PT IS PSYCHIC CONSPICUOUS AND FORMS HER OWN THEORIES.

    Devices

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

    Patients

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