BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 2223024 · Received August 19, 2011

    Report

    Report Number
    MW5021838
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANT ERODED THROUGH SKIN, VISIBLE INFECTION REQUIRING SURGICAL REMOVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability