BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2232405 · Received August 26, 2011

    Report

    Report Number
    3002807108-2011-53722
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 26, 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
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED ON (B)(6) 2011 BY A PHYSICIAN - LOCAL REFERENCE (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) ONE AMPOULE FOR REJUVENATION IN (B)(6) 2008 AND (B)(6) 2009. DURING (B)(6) 2011, THIS PATIENT EXPERIENCED NUMEROUS LUMPS/NODULES AT THE INJECTION SITE OF POLY-L-LACTIC ACID. UNSPECIFIED CORRECTIVE TREATMENT WAS PROVIDED DUE TO THE EVENT. THE OUTCOME IS UNKNOWN. THE REPORTER ASSESSED THE EVENT AS SERIOUS AND HIGHLY PROBABLE FOR THE TREATMENT WITH POLY-L-LACTIC ACID. SIGNIFICANT/RELEVANT MEDICAL HISTORY: NONE RELEVANT CONCOMITANT MEDICATIONS INCLUDE HYALURONIC ACID AND BOTULINUM TOXIN TYPE A (BOTOX). ACTION TAKEN: NOT APPLICABLE. CORRECTIVE TREATMENT: UNSPECIFIED TREATMENT. OUTCOME: UNKNOWN. (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 AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R PREV MEDS = UNKNOWN| BOTOX (CON.) (DATE OF TX: (B)(6))| HYALURONIC ACID (CON.) (DATE OF TX: (B)(6))