BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APD CATHETER

    MDR report key: 11746 · Received February 25, 1994

    Report

    Report Number
    MW1000888
    Event Type
    Injury
    Date Received
    February 25, 1994
    Date of Event
    December 31, 1993
    Report Date
    February 10, 1994
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    KPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DUE TO CATHETER DYSFUNCTION AND FATIGUE, THERE WAS CATHETER FRAGMENTATION OF THE DISTAL PORTION OF THE CATHETER. FOUR SMALL FRAGMENTS WERE LEFT IN SUBQ TISSUE AND HAD TO BE REMOVED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APD CATHETER KPM MEDI-TECH, INC. 28652

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention