BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 1202067 · Received October 10, 2008

    Report

    Report Number
    MW5008612
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    September 3, 2008
    Report Date
    October 10, 2008
    Manufacturer
    MENTOR CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERMANENT RIGHT SALINE BREAST IMPLANT, IMPLANTED 2006. RUPTURED AND WAS EXPLANTED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE BREAST IMPLANT FWM MENTOR CORPORATION 1600

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability