BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 388001 · Received April 4, 2002

    Report

    Report Number
    MW1024677
    Event Type
    Malfunction
    Date Received
    April 4, 2002
    Date of Event
    March 13, 2002
    Report Date
    March 25, 2002
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT NOTICED RIGHT BREAST IMPLANT DEFLATING. PREVIOUS DEFLATION OF THE SAME SIDE 03/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR MAMMARY IMPLANT FWM MENTOR * 152366

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR