BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRITEPRO OMNI SINGLE USE LARYNGOSCOPE HANDLE

    MDR report key: 14167858 · Received April 20, 2022

    Report

    Report Number
    MW5109208
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    April 18, 2022
    Report Date
    April 18, 2022
    Manufacturer
    FLEXICARE MEDICAL LTD.
    Product Code
    CCW
    UDI-DI
    05055788768838
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BRITEPRO OMNI STERILE SINGLE USE LARYNGOSCOPE HANDLE (MAC2) WITH BATTERIES AND FITTED BLADE - LIGHT DOES NOT WORK. BRITEPRO LIGHT FAILED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715600 BRITEPRO OMNI SINGLE USE LARYNGOSCOPE HANDLE LARYNGOSCOPE, RIGID CCW FLEXICARE MEDICAL LTD. BRITEPRO MAC 2 191101795 05055788768838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown