BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL CATHETER

    MDR report key: 360839 · Received November 9, 2001

    Report

    Report Number
    2518902-2001-00191
    Event Type
    Injury
    Date Received
    November 9, 2001
    Date of Event
    December 1, 2000
    Report Date
    September 21, 2001
    Manufacturer
    MEDCOMP MEDICAL COMPONENTS, INC.
    Product Code
    LFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BROKE INTERNALLY AT HOME. THE CATHETER HAD BEEN IMPLANTED FOR TWO WEEKS. IT WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50587 FEMORAL CATHETER HEMODIALYSIS CATHETER LFK MEDCOMP MEDICAL COMPONENTS, INC. NA M915250

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention