BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE-FILLED-2800 ROUND

    MDR report key: 148038 · Received January 9, 1998

    Report

    Report Number
    148038
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    July 14, 1997
    Report Date
    July 29, 1997
    Manufacturer
    MENTOR CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS 72 YR OLD FEMALE HAS HAD PREVIOUS MULTIPLE BREAST RECONSTRUCTION STATUS POST SIMPLE MASTECTOMIES. ON JANUARY 21, 1992, SHE HAD SALINE-FILLED BREAST IMPLANTS INSERTED. SHE NOTICED, A DECREASE IN VOLUME AFTER RECENT MAMMOGRAM. GROSS EXAM: THE RIGHT IMPLANT SHOWS A SMALL FENESTRATION ON THE IMPLANT SURFACE JUST ADJACENT TO AN EMBOSSED THICKENED RING AND WEIGHS 46.0 GMS. THE LEFT IMPLANT IS INTACT AND WEIGHS 310 GMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE-FILLED-2800 ROUND Implant MAMMARY PROSTHESIS FWM MENTOR CORP. * 58932

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization