BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESIO CATH B.CANAUD METHOD

    MDR report key: 375913 · Received February 8, 2002

    Report

    Report Number
    2518902-2002-00017
    Event Type
    Injury
    Date Received
    February 8, 2002
    Date of Event
    December 12, 2001
    Report Date
    January 21, 2002
    Manufacturer
    MEDCOMP MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2001 THAT THERE WAS BLOOD LEAKING AT THE LEVEL OF THE TUNNELIZED CATHETER WITH COLLAPSING OF THE CATHETER. TWO DAYS LATER, OPACIFICATION OF THE CATHETER AND EXTRAVASATION AT THE ARTERIAL CATHETER LEVEL WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESIO CATH B.CANAUD METHOD HEMODIALYSIS CATHETER LFJ MEDCOMP MEDICAL COMPONENTS, INC. NA M826030

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention