BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1780316 · Received July 27, 2010

    Report

    Report Number
    3003496686-2010-43006
    Event Type
    Injury
    Date Received
    July 27, 2010
    Report Date
    July 27, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS RECEIVED FROM A NURSE ON JUL-21-2010. THIS IS THE SECOND OF THREE CASES BY THE SAME REPORTER: A PATIENT WITH A HISTORY OF COLLAGENOSIS WHO RECEIVED POLY-L-LACTIC ACID (SCULPTRA) INJECTIONS, DEVELOPED NODULES 7 TO 8 MONTHS LATER. NO FURTHER RELEVANT INFORMATION WAS PROVIDED. THIS CASE IS ASSOCIATED WITH CASE (B)(4) [SAME REPORTER].

    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 Other PREV MEDS =UNKNOWN| CON MEDS =UNKNOWN