BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD URETHRAL CATHETERIZATION TRAY

    MDR report key: 5492283 · Received April 8, 2005

    Report

    Report Number
    5492283
    Event Type
    Injury
    Date Received
    April 8, 2005
    Date of Event
    April 6, 2005
    Report Date
    April 8, 2005
    Manufacturer
    BARD, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED ANAPHYLACTIC SHOCK AFTER EXPOSURE TO LATEX CATHETER; HE WAS KNOWN TO BE ALLERGIC TO LATEX; A CONTRIBUTING FACTOR TO THIS INCIDENT WAS THE PRODUCT PACKAGING, WHICH NOTES LATEX CONTENT IN VERY SMALL LETTERS, NOT EASILY VISIBLE, COMPARED TO THE LARGE LETTERS ON PACKAGE CONTAINING LATEX-FREE PRODUCT. AGAIN, THIS WAS NOT THE PRIMARY CAUSE OF THE INCIDENT, BUT IT IS CONSIDERED A CONTRIBUTING FACTOR. IT IS OUR CONCERN THAT PRODUCT LABEL(S) DO NOT CONSISTENTLY USE BOLD OR LARGE LETTERS TO NOT THE PRODUCT CONTAINS LATEX, AS THEY SEEM TO DO WHEN THEY NOTE THE PRODUCT IS LATEX FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD URETHRAL CATHETERIZATION TRAY URINARY CATHETER KOD BARD, INC. 76100693

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R