BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 1901785 · Received November 4, 2010

    Report

    Report Number
    1901785
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFLATED RIGHT BREAST SALINE IMPLANT (SPONTANEOUS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR