BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2850845 · Received November 20, 2012

    Report

    Report Number
    3002807108-2012-84799
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P0310050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: NODULES ARE CONSIDERED A COMMON AND LISTED EVENT FOR POLY-L-LACTIC ACID. MOST EVENTS OF THIS NATURE RESOLVED SPONTANEOUSLY OVER TIME. THESE EVENTS ARE TYPICALLY A COSMETIC CONCERN AND NOT A MAJOR MEDICAL ISSUE THAT WOULD RESULT IN PERMANENT DISABILITY, A LIFE-THREATENING CONDITION, OR FATAL INJURY.

    Description of Event or Problem · 1

    INITIAL INFORMATION FOR THIS SERIOUS UNSOLICITED REPORT (B)(4) WAS REPORTED ON THE HOMEPAGES OF (B)(4) POSED BY A PHYSICIAN AND FORWARDED BY LOCAL AFFILIATE ON (B)(4) 2012. THIS CASE INVOLVES A FEMALE PT (AGE UNSPECIFIED) WHO RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) AND COLLAGEN (EVOLENCE) (DERMAL FILLER) IN ORDER TO REPLACE LOST COLLAGEN AND INCREASE THE VOLUME OF DEPRESSED AREAS, PARTICULARLY TO CORRECT SKIN DEPRESSIONS. THE PT VISITED THE PRIVATE CLINIC IN THE FIRST PLACE IN ORDER TO REMOVE A MOLE. DURING REMOVAL OF THE MOLE, POLY-L-LACTIC ACID WAS SUGGESTED FOR THE PT AND THE PHYSICIAN TREATED THE PT WITH POLY-L-LACTIC ACID IN THE DEEP DERMIS A FEW WEEKS LATER. THE POLY-L-LACTIC ACID TREATMENT WAS REPEATED TWO MONTHS LATER, BUT AT THAT TIME, SHE ALSO RECEIVED TREATMENT WITH COLLAGEN AT THE ROOT OF HER NOSE. FOUR MONTHS AFTER TREATMENT, THE PT EXPERIENCED BLUE COLOR IN HER SKIN AROUND HER DIMPLES AND AFTER A WHILE, WORSENING WITH LARGE NODULES, BURNING PAIN, PRURITUS AND SWELLING IN THE INJECTED AREAS. THE AFFLICTIONS HAS UNSUCCESSFULLY BEEN TREATED WITH CORTISONE, MASSAGE, LASER AND TRANQUILIZERS. ACCORDING TO A SKIN PHYSICIAN'S ASSESSMENT, IT WAS NO GOOD REASONS TO NOT CARRY OUT THE INJECTIONS, BUT THE PT'S AFFLICTIONS WITH A BLUE COLOR IN THE FACE, BURNING PAIN, PRURITUS AND SWELLINGS IS PROBABLY DUE TO THE TREATMENT. NO MEDICAL HISTORY OR CONCOMITANT MEDICATIONS WERE PROVIDED. CORRECTIVE TREATMENT: CORTISONE, LASER, TRANQUILIZERS AND MASSAGE. ACTION TAKEN: NOT APPLICABLE. OUTCOME: NOT RECOVERED.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R PRE MEDS = UNKNOWN| CON MEDS = UNKNOWN