BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 2901596 · Received January 3, 2013

    Report

    Report Number
    3002807108-2012-92797
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT (B)(4) 2012: AUTOIMMUNE REACTION AND DISFIGUREMENT CLAIMED BY THE CONSUMER WERE NOT CONFIRMED BY THE TREATING PHYSICIAN. A CASUAL RELATIONSHIP WITH SCULPTRA CANNOT BE ASSESSED.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED FROM A PHYSICIAN ON (B)(6) 2012: A FEMALE PATIENT CURRENTLY IN HER (B)(6) RECEIVED ONE INJECTION OF POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT NUMBER AND EXPIRATION DATE UNKNOWN) IN HER CHEEKS IN (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT BELIEVED THAT SHE HAD DEVELOPED SOME TYPE OF AUTOIMMUNE REACTION/AUTOIMMUNE DISORDER AFTER DOING SOME INTERNET RESEARCH. HER COMPLAINT WAS SENT BY E-MAIL TO THE REPORTING PHYSICIAN INDICATING THAT SHE HAD A BURNING SENSATION, AND THAT SHE HAD BEEN SO DISFIGURED, THAT SHE HAD TO LEAVE HER JOB. THE REPORTING PHYSICIAN NOTED THAT THE PATIENT WAS NEVER HAPPY WITH THE RESULT OF THE POLY-L-LACTIC ACID INJECTION, AND THAT SHE HAD ALWAYS FELT THAT SHE WAS EXCEPTIONALLY SWOLLEN. THE REPORTING PHYSICIAN MENTIONED THAT HE THOUGHT THAT THE PATIENT WAS A LITTLE CRAZY, AS HE NEVER GOT THAT FEELING. THE PHYSICIAN ALSO INDICATED THAT HE HAD USED A LOT OF POLY-L-LACTIC ACID IN GENERAL, AND THAT HE NEVER HAD THAT REACTION, SO HE WAS A LITTLE SUSPICIOUS ABOUT WHAT THE PATIENT SAID. LASTLY, THE PHYSICIAN REPORTED THAT HE HAD NOT SEEN THE PATIENT IN ABOUT 4-5 MONTHS FROM THE TIME OF REPORT, AND THAT THE LAST TIME THAT HE HAD SEEN HER, HE STILL DID NOT THINK THAT SHE WAS DISFIGURED. NO FURTHER RELEVANT INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317 SCULPTRA FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PREV MEDS = UNK| CON MEDS = UNK