BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 2973903 · Received February 13, 2013

    Report

    Report Number
    MW5029035
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MENTOR CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 1997, PATIENT HAD A SALINE BREAST IMPLANT MANUFACTURED BY MENTOR CORP PLACED. APPROX. (B)(6) 2013, SHE NOTED DIFFERENCE IN SIZE IN THAT THE LEFT IMPLANT APPEARED SMALLER. SHE WAS SEEN IN MY OFFICE ON (B)(6) 2013 AND WAS FELT TO HAVE A DEFLATION. SHE WAS TAKEN TO SURGERY ON (B)(6) 2013 AT WHICH TIME HER LEFT IMPLANT WAS FOUND TO BE PARTIALLY DEFLATED. IT WAS REMOVED AND REPLACED WITH A NEW SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64279 MENTOR SMOOTH SALINE BREAST IMPLANT FWM MENTOR CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR