BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 1050112 · Received May 21, 2008

    Report

    Report Number
    MW5006989
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    August 21, 2007
    Report Date
    May 21, 2008
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL REMOVE AND REPLACE BREAST IMPLANTS. RIGHT BREAST IMPLANT RUPTURED AND CAPSULORRHAPHY, LEFT BREAST CAPSULORRHAPHY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR