BEUDAMED
    FDA Adverse Event Other Summary report: N

    IDEAS PORT

    MDR report key: 19094 · Received October 26, 1994

    Report

    Report Number
    1033972-1994-00005
    Event Type
    Other
    Date Received
    October 26, 1994
    Date of Event
    September 3, 1994
    Report Date
    October 6, 1994
    Manufacturer
    IDEAS FOR MEDICINE
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE EXPLANTED DUE TO SUSPECTED LEAK IN CATHETER; DEVICE EVALUATED AFTER EXPLANT; ALL TESTS PERFORMED BY MANUFACTURER INDICATE A PROPERLY FUNCTIONING DEVICE. DEVICE PURCHASED IN JAN 93, AND EXPLANTED 9/1/94. FINAL DETERMINATION CANNOT BE MADE DUE TO INABILITY TO DUPLICATE/CONFIRM EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDEAS PORT Implant TITANIUM VASSCULAR ACCESS PORT LJT IDEAS FOR MEDICINE IP4001 T073092-41

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other