BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2170065 · Received July 13, 2011

    Report

    Report Number
    3002807108-2011-43180
    Event Type
    Injury
    Date Received
    July 13, 2011
    Report Date
    July 13, 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 (B)(6) 2011 BY SALES REP AND (B)(6) 2011 BY A NURSE - LOCAL REFERENCE (B)(4). THIS CASE INVOLVED A MALE, TREATED WITH POLY-L-LACTIC ACID ON AN UNKNOWN DATE (INDICATION AND DOSAGES WERE NOT REPORTED). THE NURSE REPORTED THAT THE PATIENT HAD COME TO SEE HER AT THE CLINIC, HAVING RECEIVED HIS POLY-L-LACTIC INJECTIONS AT ANOTHER CLINIC. HE PRESENTED WITH A VISIBLE NODULE ON HIS LEFT CHEEK AND 2 PALPABLE ONES HIGHER AROUND THE CHEEK IMPLANT. HE WAS GIVEN SALINE INJECTED INTO THE NODULES TO TRY TO BREAK THEM UP. HE WAS GIVEN REASSURANCE AS TO THE LIKELY SELF LIMITING NATURE OF THESE NODULES. HIS MAIN CONCERN IS THAT PROTOCOLS WERE NOT FOLLOWED AT THE PREVIOUS CLINIC. SIGNIFICANT/RELEVANT MEDICAL HISTORY AND RELEVANT CONCOMITANT MEDICATIONS WERE NOT REPORTED. ACTION TAKEN: UNKNOWN. OUTCOME - UNKNOWN. A PHARMACEUTICAL TECHNICAL COMPLAINT HAS BEEN INITIATED. (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.

    Patients

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