BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION 400

    MDR report key: 726688 · Received May 18, 2006

    Report

    Report Number
    726688
    Event Type
    Malfunction
    Date Received
    May 18, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 18, 2006
    Manufacturer
    KENDALL
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE CARING FOR THIS PATIENT SAID THE PATIENT ARRIVED IN THE SICU FROM THE EMERGENCY DEPARTMENT. IT IS THEIR PRACTICE TO SWITCH OUT THE URIMETER WHEN THE PATIENT ARRIVES ON THE UNIT. THE URIMETER STARTED TO LEAK WHERE THE CLEAR PLASTIC FACE WAS MOLDED TO THE WHITE PLASTIC BACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION 400 URIMETER EYZ KENDALL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *