BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1802611 · Received August 12, 2010

    Report

    Report Number
    3003496686-2010-45955
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 21, 2010
    Report Date
    August 12, 2010
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED FROM A CONSUMER ON 02-AUG-2010: CASE INVOLVED A (B)(6) FEMALE WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT# AND EXP DATE UNKNOWN) FOR COSMETIC PURPOSES. CONSUMER REPORTED THAT SHE EXPERIENCED TENDERNESS AND "A LUMP" FOLLOWING USE OF POLY-L-LACTIC ACID WHICH WERE INJECTED AT THE TOP OF THE OUTER CHEEK AND A SMALL AMOUNT UNDER THE EYE. SHE RECEIVED TWO THERAPY SESSIONS ON (B)(6) 2010 AND ON (B)(6) 2010. FOLLOWING THE FIRST SESSION, SHE EXPERIENCED TENDERNESS, WHICH EVENTUALLY WENT AWAY. SHE STATED SHE WAS INSTRUCTED TO MASSAGE THE AREA. FOLLOWING THE SECOND SESSION, SHE AGAIN EXPERIENCED TENDERNESS AND A NON-VISIBLE NODULE ON EACH SIDE OF HER CHEEK. THE NODULES WERE AT DIFFERENT SITES THAN THE TENDERNESS. THE NODULES AND TENDERNESS FOLLOWING THE SECOND INJECTION, HAD NOT RESOLVED AT TIME OF THIS REPORT. SHE STATED THAT DUE TO THE CORRECTION FROM THE TWO SESSIONS, HER EYES ARE MORE HOLLOW LOOKING BENEATH THE EYES. NO CONCOMITANT MEDICATIONS OR MEDICAL HISTORY REPORTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA FACIAL FILLER LMH SANOFIAVENTIS U.S. LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN