BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSURE

    MDR report key: 1980010 · Received January 31, 2011

    Report

    Report Number
    MW5019231
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 1, 2007
    Report Date
    January 31, 2011
    Manufacturer
    UNSURE
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS SALINE BREAST IMPLANTS AND DEVELOPED A DIFFUSE LARGE B CELL LYMPHOMA 10-15 YEARS AFTER THEY WERE PUT IN. THE LYMPHOMA OCCURRED IN THE INTRA-MAMMARY LYMPH SYSTEM. DATES OF USE: 15 YEARS. REASON FOR USE: COSMETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSURE SALINE IMPLANT FWM UNSURE UNSURE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening