BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)

    MDR report key: 2042135 · Received March 31, 2011

    Report

    Report Number
    3003496686-2011-17820
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    October 10, 2008
    Report Date
    March 31, 2011
    Manufacturer
    SANOFIAVENTIA U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    PO30050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS SERIOUS UNSOLICITED REPORT WAS RECEIVED FROM A PHYSICIAN VIA OUR AFFILIATE (B)(4) ON (B)(6) 2011. THIS CASE INVOLVES A (B)(6) FEMALE WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA). DURING EACH SESSION POLY-L-LACTIC ACID WAS DILUTED WITH 6 ML OF STERILE WATER PLUS 1 ML OF LIDOCAINE FOR FACIAL REJUVENATION. TREATMENT WAS ADMINISTERED ON: (B)(6) 2008 WITH INJECTIONS TO THE CHEEKS AND MARIONETTE LINES; (B)(6) 2008 INJECTIONS TO THE CHEEKS AND CHEEKBONES; AND (B)(6) 2008 WITH INJECTIONS TO THE CHEEKS AND MARIONETTE LINES. FROM (B)(6) 2008, THIS PT EXPERIENCED TWO NODULES, 2 CM IN SIZE, IN THE RIGHT CHEEKBONE ON THE OUTSIDE OF THE FACE. THE NODULES WERE TREATED WITH LESION SUBCISION AND CORTICOIDS. SURGICAL INTERVENTION WAS NOT REQUIRED AND THE PT RECOVERED ON (B)(6) 2008. DURING (B)(6) 2008, INFLAMMATORY REACTION WAS EXPERIENCED. THE PT RECOVERED SOMETIME THAT SAME MONTH. SINCE (B)(6) 2011, AND INFLAMMATORY REACTION WITH INDURATED NODULES ACROSS THE FACE FROM 2-6 CM WERE NOTED. THE PHYSICIAN DESCRIBED THE ADVERSE EVENT AS VISIBLE NODULES IN ALMOST ALL THE FACE, ESPECIALLY IN THE CHEEK. THE FIRST NODULE APPEARED ON (B)(6) 2008 AND AT THE TIME OF THIS REPORT THERE WERE MORE THAN TEN. THE EVENT IS ONGOING AND HAS LASTED MORE THAN TWO YEARS, BUT HAS CAUSED NO BODILY DYSFUNCTION OR PERMANENT DAMAGE. NO BIOPSY WAS TAKEN. OTHER SUSPECT DRUGS: NONE. SIGNIFICANT/RELEVANT MEDICAL HISTORY INDICATES THIS PT HAS HAD OTHER ESTHETIC TREATMENTS WITH NO SIMILAR EVENTS. RELEVANT CONCOMITANT MEDICATIONS INCLUDE LIDOCAINE. ACTION TAKEN: NOT APPLICABLE. CORRECTIVE TREATMENT: LESION SUBCISION AND CORTICOIDS. OUTCOME: NOT RECOVERED. PHYSICIAN/REPORTER CAUSALITY: NOT INDICATED. A PTC (PRODUCT TECHNICAL COMPLAINT) HAS BEEN INITIATED FOR THIS REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-L-LACTIC ACID (POLY-L-LACTIC ACID) FACIAL FILLER LMH SANOFIAVENTIA U.S. LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other LIDOCAINE (CON.) (B)(6) 2008| PREV MEDS = UNK