BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 2538270 · Received April 10, 2012

    Report

    Report Number
    3002807108-2012-24279
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    October 1, 2011
    Report Date
    April 10, 2012
    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
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: (B)(4) COMMENT DATED (B)(4) 2012: THE PT WAS DIAGNOSED WITH NON HODGKIN'S LYMPHOMA 12 YRS AFTER RECEIVING SCULPTRA. EVEN THOUGH NHL IS SITUATED AT THE SAME PLACE WHERE INJECTIONS WERE GIVEN THE CAUSAL RELATIONSHIP APPEARS TO BE UNLIKELY AS SCULPTRA IS EXPECTED TO STAYS LOCALLY IN THE BODY ONLY FOR 2 YRS. THE USE OF COSMETIC PRODUCT POLYMETHYLMETHACRYLATE (ARTECOLL) BY THE PT MIGHT HAVE TRIGGERED THE DEVELOPMENT OF THE EVENT. ADD¿L MEDICAL INFO SUCH AS RELEVANT MEDICAL HISTORY, CONCOMITANT DRUGS AND TREATING PHYSICIANS OPINION WILL BE REQUIRED FOR FURTHER ASSESSMENT OF THE CASE.

    Description of Event or Problem · 1

    INITIAL INFO FOR THIS SERIOUS UNSOLICITED REPORT WAS REPORTED BY LOCAL HEALTH AUTHORITY ((B)(6)) VIA A PHARMACIST AND FORWARDED BY AFFILIATE ((B)(4)). THIS CASE INVOLVES A (B)(6) FEMALE PT WHO WAS DIAGNOSED WITH NON-HODGKIN LYMPHOMA (NHL) IN (B)(6) 2011. THE CONSUMER WAS SUSPECTING THAT NHL IS AN ADVERSE REACTION OF COSMETIC PRODUCT POLYMETHYLMETHACRYLATE (ARTECOLL) INJECTED ABOUT 5 YRS AGO (2007) OR POLY-L-LACTIC ACID (SCULPTRA) INJECTED ABOUT 13 YRS AGO (1999). THESE PRODUCTS WERE SUSPECTED BECAUSE NHL IS SITUATED AT THE SAME PLACE WHERE INJECTIONS WERE GIVEN. NO INTERACTION WITH OTHER HEALTH PRODUCT WAS SUSPECTED. NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. NO MEDICAL HISTORY OR CONCOMITANT MEDICATIONS WERE PROVIDED. CORRECTIVE TREATMENT: UNK. ACTION TAKEN: NOT APPLICABLE. OUTCOME: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA (POLY-L-LACTIC ACID) FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L PREV MEDS =UNK| CON MEDS =UNK