BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3913154 · Received June 11, 2014

    Report

    Report Number
    2024601-2014-00311
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    September 1, 2009
    Report Date
    September 1, 2009
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    PT REPORTED ON THE ANNUAL QUESTIONNAIRE OF CASE OF NON-HODGKINS LYMPHOMA. THERE HAVE BEEN SEVERAL ATTEMPTS TO GATHER INFO REGARDING THIS CASE, BUT THERE HAS BEEN NO PROGRESS MADE. IF/WHEN NEW INFO IS PROVIDED IT WILL BE FORWARDED. THIS FILE IS FOR THE RIGHT SIDE. SEE MRF 2024601-2014-00312 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343879 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1551301

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention