BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 491103 · Received September 27, 2003

    Report

    Report Number
    MW1029795
    Event Type
    Injury
    Date Received
    September 27, 2003
    Date of Event
    April 15, 2003
    Report Date
    September 27, 2003
    Manufacturer
    MENTOR CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2003 PT HAD THEIR LEFT BREAST IMPLANT BEGIN TO LEAK! THEY ARE MENTOR IMPLANTS, SILTEX TYPE 2600 LOT #133460! PT CALLED THEIR PLASTIC SURGEON. HE SAID HE WOULD SEE PT IN THE MORNING! THE NEXT DAY PT WENT IN TO SEE HIM, HE SAID HE HAD TO GET PT'S RECORDS OUT OF STORAGE. PT WAS UNABLE TO FIND THEIRS TO SEE IF PT HAD THE 10 YEAR WARRANTY! THEY ACTUALLY ARE GUARANTEED FOR LIFE SO PT ASSUMED THEY WERE COVERED IN CASE OF AN EVENT LIKE THIS! NOT THE SURGEONS FEES OF $3000! DR. TOLD PT SALINE WON'T HURT THEM AND TO GET BACK WITH HIM WHEN PT IS ABLE TO COME UP WITH THE CASH TO HAVE THIS FIXED! PT HAS HAD TWO INFECTIONS AS A RESULT NOT TO MENTION HOW UNCOMFORTABLE IT IS, PT IS ALSO CONSTANTLY TIRED SICK AT THEIR STOMACH AND THERE ARE NOW STRANGE LUMPS FORMING IN THEIR DEFLATED BREAST! IS THERE ANYTHING PT CAN DO TO GET HELP WITH THE COST OF THIS SURGERY "SHOULN'Y "MENTOR PAY FOR PART". PLEASE HELP ME AS WELL AS LOSING MY JOB", AND NOT TO MENTION WHAT THIS HAS DONE TO PT'S SELF ESTEEM AND THEIR PERSONAL LIFE AS WELL, PT IS WORRIED ABOUT THEIR HEALTH! PLEASE HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SILTEX 2600 BREAST IMPLANT FWM MENTOR CORPORATION 2600 133460

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention