BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR SMOOTH ROUND MOD

    MDR report key: 751425 · Received July 21, 2006

    Report

    Report Number
    MW1039809
    Event Type
    Other
    Date Received
    July 21, 2006
    Report Date
    July 13, 2006
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 01/17/2005 AUGMENTATION WITH MENTOR 300CC IMPLANTS. FILLED TO 325CC BILATERALLY. NOW DESIRES TO BE SMALLER IN SIZE-07. ON 07-13-06 PT UNDERWENT BILATERAL IMPLANT REMOVAL-IMPLANTS REMOVED INTACT. AUGMENTATED WITH 250CC MENTOR GEL IMPLANTS. ALSO BILATERAL MASTOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SMOOTH ROUND MOD PROFILE SALINE/MAMMARY PROSTHESIS FWM MENTOR * 554 7661
    2 MENTOR SMOOTH ROUND MOD PROFILE SALINE MAMMARY PROSTHESIS FWM MENTOR * 5547661

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other
    2