BEUDAMED
    FDA Adverse Event Other Summary report: N

    MRI

    MDR report key: 15108 · Received May 6, 1994

    Report

    Report Number
    15108
    Event Type
    Other
    Date Received
    May 6, 1994
    Date of Event
    March 23, 1994
    Report Date
    May 5, 1994
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT BECAME INFECTED AND REQUIRED REMOVAL. UPON REMOVAL IT WAS DETERMINED THAT THERE WAS A DEFECT, THE BLADDER WAS PARTIALLY OUT OF RESERVOIR. DEVICE INSERTED 11/12/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI Implant INFUSAPORT LJT BARD ACCESS SYSTEMS, INC. 36FD4220

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other