BEUDAMED
    FDA Adverse Event Summary report: N

    HALAX 50

    MDR report key: 4426418 · Received December 17, 2014

    Report

    Report Number
    4426418
    Date Received
    December 17, 2014
    Date of Event
    May 19, 2014
    Report Date
    December 9, 2014
    Manufacturer
    WALDMANN LIGHTING
    Product Code
    KZF
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    TEARING AND EXPOSED CORE ON THE EXAM LIGHT SLEEVES HAVE MANY FACTORS, SUCH AS INFECTION CONTROL ISSUES BECAUSE THE AREA CANNOT BE CLEANED OR DISINFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829584 HALAX 50 LIGHT, EXAMINATION KZF WALDMANN LIGHTING 6600-0887-702 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *