BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 1820709 · Received August 27, 2010

    Report

    Report Number
    3003496686-2010-49528
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    August 26, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS REPORTED BY A PLASTIC SURGEON ON 19-AUG-2010 AND UPON MEDICAL REVIEW, HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT(S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE - (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE PT WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) THERAPY TO THE ANTERIOR NECK IN (B)(6)-2010. THE DILUTION (NOS) WAS UP TO 10 ML. NO ADDITIONAL TREATMENT DETAILS WERE MENTIONED. WHEN THE PT RETURNED TWO MONTHS LATER TO RECEIVE A SECOND TREATMENT, THE PLASTIC SURGEON NOTICED THAT THE PT'S SKIN HAD NOT GOTTEN TAN AROUND THE INJECTION AREA OF APPROXIMATELY 5 CM HIGH AND IN MAXIMUM 12 CM WIDE. THE SECOND TREATMENT WAS NOT PERFORMED. THE PLASTIC SURGEON SAW THE PT AGAIN IN THE BEGINNING OF AUGUST AND AT THE TIME PIGMENT HAD FORMED A BIT AT THE LOWER PART OF THE AREA BUT THE LIGHT BLOTCH WAS STILL CLEARLY VISIBLE. RELEVANT MEDICAL HISTORY: PT UNDERWENT LIFT OF ANTERIOR NECK IN THE SPRING OF 2009 WHICH HEALED IN A NORMAL WAY. RELEVANT CONCOMITANT MEDICATIONS: NOT MENTIONED. ACTION TAKEN: PERMANENTLY DISCONTINUED. CORRECTIVE TREATMENT - UNK. OUTCOME - NOT RECOVERED/ NOT RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other PREV MEDS = UNK| CON MEDS = UNK