BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2221626 · Received August 19, 2011

    Report

    Report Number
    3002807108-2011-52002
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    August 19, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED ON 15-AUG-2011 BY A NURSE - LOCAL REFERENCE (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE PT WHO WAS TREATED WITH POLY-L-LACTIC ACID, BATCH A0039, ON (B)(6) 2011. FOR BOTH TREATMENTS, POLY-L-LACTIC ACID WAS RECONSTITUTED WITH 6 ML OF STERILE WATER AND 2 ML OF XYLOCAINE 2% (LIDOCAINE HYDROCHLORIDE). THE FIRST VIAL WAS HYDRATED ONE WEEK PRIOR TO TREATMENT AND THE SECOND VIAL WAS HYDRATED 24 HOURS PRIOR TO TREATMENT. LOCATION OF INJECTIONS AND INDICATION WERE NOT REPORTED. AFTER BOTH TREATMENTS, THE PT REPORTED SHE EXPERIENCED ACNE BREAKOUTS WHICH REQUIRED TREATMENT WITH ANTIBIOTIC NOS. SHE ALSO REPORTED MICRONODULES, MAINLY AFTER THE SECOND TREATMENT. THE MICRONODULES ARE PRESENT IN THE MARIONETTE AND NASOLABIAL AREAS. THEY ARE PALPABLE, BUT NOT VISIBLE. THE OUTCOME OF THE EVENT IS UNK. SIGNIFICANT/RELEVANT MEDICAL HISTORY: NOT INDICATED. RELEVANT CONCOMITANT MEDICATION: LIDOCAINE HYDROCHLORIDE (XYLOCAINE). ACTION TAKEN: UNK. CORRECTIVE TREATMENT: ANTIBIOTIC NOS. OUTCOME: UNK. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 16-AUG-2011: THIS (B)(6) FEMALE PT DEVELOPED ACNE AFTER BOTH SCULPTRA ADMINISTRATION WHICH REQUIRED ANTIBIOTICS. MEDICAL EVAL OF THIS CASE IS CONFOUNDED BY THE HIGH PREVALENCE OF ACNE IN THE GENERAL POPULATION. THE ADD'L INFO SUCH AS RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATION, ANY HISTORY OF HORMONE REPLACE THERAPY WILL BE REQUIRED FOR FURTHER ASSESSMENT OF THIS CASE.

    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. A0039

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R XYLOCAINE (CON.)| PREV MEDS = UNK