BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2232406 · Received August 26, 2011

    Report

    Report Number
    3002807108-2011-53653
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON MEDICAL REVIEW THIS REPORT HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE. THIS CASE WAS REPORTED ON 23-AUG-2011 BY A DERMATOLOGIST - LOCAL REFERENCE (B)(4). THIS CASE INVOLVES A FEMALE PATIENT (AGE UNKNOWN) WHO RECEIVED TWO TREATMENTS WITH POLY-L-LACTIC ACID (SCULPTRA) (DOSAGE, INDICATION, THERAPY DATES, BATCH NUMBER AND LOT NUMBER UNKNOWN). AFTER THE SECOND SESSION WITH POLY-L-LACTIC ACID, THE PATIENT EXPERIENCED NODULES ON HER FOREHEAD. FIVE VISIBLE NODULES WERE NOTED. THE TREATING PHYSICIAN PRESCRIBED UNSPECIFIED ANTIBIOTICS FOR CORRECTIVE TREATMENT. THE PHYSICIAN FELT THE REASON OF THE NODULE OCCURRENCE MIGHT BE DUE TO MAKE-UP AND SKIN DISINFECTANT. SIGNIFICANT/RELEVANT MEDICAL HISTORY: UNKNOWN RELEVANT CONCOMITANT MEDICATIONS: UNKNOWN. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: UNSPECIFIED ANTIBIOTICS. OUTCOME: NOT RECOVERED/NOT RESOLVED.

    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 UNK Other| R CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN