BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2011865 · Received March 4, 2011

    Report

    Report Number
    3003496686-2011-12227
    Date Received
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) RECEIVED ON (B)(6) 2011 BY AESTHETIC PHYSICIAN VIA SALES REP. ORIGINAL SOURCE PHYSICIAN. THIS CASE INVOLVES A FEMALE PT, TREATED ON UNSPECIFIED DATE WITH POLY-L-LACTIC ACID (SCULPTRA), INJECTION AREA, DOSAGE, DILUTION NOT AVAILABLE. ABOUT TWO YEARS AGO, SHE EXPERIENCED PAPULES AT FACE. THE PHYSICIAN SHOWED A PHOTO OF THE PT TO OUR SALES REP. SHE ADDED THAT AFTER A CORRECTIVE TREATMENT WITH CORTISONE, THE PT FULLY RECOVERED. ADD'L INFO REPORTED AS SOON AS POSSIBLE. (B)(4). ADD'L INFO RECEIVED FROM THE AESTHETIC PHYSICIAN BY PHONE ON (B)(6) 2011. WE SUCCEEDED IN CONTACTING THE AESTHETIC PHYSICIAN BY PHONE. SHE TOLD US THE CASE OCCURRED 4 YEARS AGO AND NOT 2 YEARS AGO AS PREVIOUSLY REPORTED BY OUR SALES REP. THE PT WAS TREATED ON THE FACE AND ABOUT SIX MONTHS LATER, THE PT EXPERIENCED PAPULES AT THE FACE. THE REPORTER CONFIRMED THAT THE PT FULLY RECOVERED AFTER THE ADMINISTRATION OF CORTISONE. NO FURTHER INFO WAS AVAILABLE.

    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 UNK Other PREV MEDS =UNK| CON MEDS =UNK