BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 2122074 · Received June 3, 2011

    Report

    Report Number
    3003496686-2011-33320
    Date Received
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    SANOFIAVENTIS U.S. LLC
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED FROM A PHYSICIAN WITH ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: A (B)(6) PATIENT RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT # AND EXP DATE UNKNOWN) IN (B)(6) 2010. THE PATIENT HAS HAD SEVERAL RECONSTRUCTIVE SURGERIES AND PROCEDURES AND TREATMENTS AFTER A MOTOR VEHICLE ACCIDENT. HE HAD 20CC OF SILICONE OVER 15 YEARS PRIOR TO SALINE IN THE AREA. PATIENT HAD ONE TREATMENT OF POLY-L-LACTIC ACID 9 1/2 MONTHS AGO IN THE CHEEK AREA. HE ALSO HAD "TOP FRAXEL LASER" DONE SINCE THEN. PHYSICIAN DESCRIBED THIS AS A SUPER HOT LASER THAT HEATS BLOOD VESSELS UNDER SKIN. THE PATIENT ALSO HAD "V BEAM LASER" DONE AFTER TREATMENT WITH POLY-L-LACTIC ACID. PHYSICIAN REPORTED THAT ALL THIS MAY HAVE ACCENTUATED THE GRANULOMA AS IT IS GETTING BIGGER. THE PATIENT IS GOING FOR A PROCEDURE ON FRIDAY TO HAVE IT REMOVED. PHYSICIAN CALLED THE PROCEDURE (SANAS EXPLORATION). 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 51 YR Other CON MEDS = UNK| PREV MEDS = UNK