BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3402996 · Received October 7, 2013

    Report

    Report Number
    2024601-2013-00856
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    September 9, 2009
    Report Date
    September 9, 2009
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PATIENTS IN THE (B)(4) STUDY IN THE LABELING FOR SILICONE BREAST IMPLANTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTS A CASE OF LYMPHOMA ON THE BREAST IMPLANT FOLLOW UP STUDY ANNUAL QUESTIONNAIRE. SEVERAL ATTEMPTS WERE MADE TO DETERMINE IF TYPE OF LYMPHOMA, BUT THE OFFICE WAS UNABLE TO VERIFY THE INFORMATION. THIS FILE IS FOR THE LEFT SIDE, SEE MFR 2042601-2013-0057 FOR THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507072 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1478533

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention