BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 1202072 · Received October 10, 2008

    Report

    Report Number
    MW5008613
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    February 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    MENTOR, INC
    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

    THE PT UNDERWENT SURGERY FOR THE REMOVAL OF A RIGHT RUPTURED BREAST IMPLANT. THE OLD IMPLANT WAS REMOVED AND WAS STILL LEAKING SALINE. A NEW SALINE IMPLANT WAS PUT IN AND THE OLD ONE WAS SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR BREAST IMPLANT NONE FWM MENTOR, INC MENTOR BREAST

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability