BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1202356 · Received October 11, 2008

    Report

    Report Number
    MW5008661
    Event Type
    Malfunction
    Date Received
    October 11, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 11, 2008
    Manufacturer
    UNKNOWN
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN THE YEAR 2000, I WAS DIAGNOSED WITH CANCER AND RECEIVED A "PORT-A-CATH L70888" IN MY LEFT ARM. WHEN REMOVED IN 2001, I ASKED TO RETAIN THE DEVICE. I DID SOAK THE DEVICE IN BLEACH AT THAT TIME TO STERILIZE AND REMOVE TISSUE. I WOULD PERIODICALLY LOOK AT THE DEVICE. TODAY I WAS SHOWING IT TO MY SON AND NOTICED A THIN LAYER OF THE OUTER SHELL- A TYPE OF PLASTIC- WAS PEELING OFF FROM THE PORT. I DO NOT KNOW IF THIS IS A CONCERN FOR THE PRODUCT'S SHELF LIFE OR NOT, IT HAS NOT BEEN STORED IN ANY KIND OF PROTECTIVE PACKAGING. I DID FEEL IT SHOULD BE BROUGHT TO YOUR ATTENTION. THE BODY GROWS A CAPSULE THAT ATTACHES TO THIS ITEM WHILE IT'S IN HUMAN TISSUE. IF THIS FLAKING OF THE OUTER SHELL IS A RESULT OF DEVICE DETERIORATION OVER 7 YEARS; MY CONCERN WOULD BE ITS AFFECT ON A CANCER PT. IF IT'S THE RESULT OF DETERIORATION FROM BEING EXPOSED TO AIR AND HANDLING, THEN IT PROBABLY IS NOT AN ISSUE. MY PORT-A-CATH WAS USED FOR CHEMOTHERAPY TREATMENTS FOR 6 MONTHS USING F5U, CYTOXIN, METHOTREXATE ALONG WITH OTHER DRUGS FOR NAUSEA ETC.DATES OF USE: 2000-2001. DIAGNOSIS OR REASON FOR USE: BREAST CANCER, CHEMOTHERAPY TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PORT-A-CATH LJT UNKNOWN L70888

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR