BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1893415 · Received November 5, 2010

    Report

    Report Number
    3003496686-2010-66565
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 5, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO REPORTED BY A PHYSICIAN TO A SALES REPRESENTATIVE ON 29-OCT-2010, AND ADDITIONAL INFORMATION WAS RECEIVED FROM AN OFFICE MANAGER ON BEHALF OF THE PHYSICIAN ON 02-NOV-2010: A (B)(6) FEMALE PT RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNK, EXPIRATION DATE UNK) ON (B)(6) 2010, FOR THE FIRST TIME, FOR COSMETIC REASONS. SHE RECEIVED POLY-L-LACTIC ACID ALONG WITH LIDOCAINE AS PER OFFICE PROTOCOL. SHE WAS INJECTED IN HER TEMPLE AND CHEEK AREA AND "ALL OVER HER FACE". TWO WEEKS AFTER HER INJECTION ((B)(6) 2010), SHE REPORTED BUMPS ALONG THE INJECTION SITE ON HER TEMPLE, UNDER HER SKIN. THE RPTR DID NOT KNOW THE SIZE OF THE BUMPS. SHE CAME INTO THE OFFICE ON (B)(6) 2010. NO TREATMENT WAS GIVEN TO THE PT, BUT SHE DID RECEIVE MASSAGE THERAPY. CONCOMITANT MEDICATIONS INCLUDED BLOOD PRESSURE MEDICATION AND A SLEEP AIDE. MEDICAL HISTORY INCLUDED IRREGULAR HEART BEAT AND (B)(6). SHE WAS SCHEDULED TO COME TO THE OFFICE ON (B)(6) 2010, FOR A FOLLOW-UP APPOINTMENT. THE RPTR WAS NOT SURE WHETHER OR NOT THE BUMPS WERE ONGOING AT THE TIME OF THE REPORT. THE PT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT ON (B)(6) 2010. NO FURTHER RELEVANT INFO WAS 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 61 YR Other ANTIHYPERTENSIVE| ALL OTHER THERAPEUTIC PRODUCTS| LIDOCAINE| PREV MEDS = UNKNOWN