BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRITEPRO MAX

    MDR report key: 19890736 · Received August 2, 2024

    Report

    Report Number
    3006061749-2024-00029
    Event Type
    Death
    Date Received
    August 2, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDTIONAL COMMENTS RECIEVED REGARDING THE EVENT STATE ' THE PASSING OF THE BABY WAS NOT BECAUSE OF THE LARYNGOSCOPE'. UDI INFORMATION HAS NOT BEEN ABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    EVENT DETAILS AS DECRIBE TO MANAUFACTUIRER 'LIGHT WAS FLICKERING DURING INTUBATION ON 24 WEEK BABY. IF BLADE WAS PUSHED DOWN THE LIGHT WOULD STAY ON.' 'THE BABY HAD ANATOMICAL ISSUES AND COULD NOT VENTILATE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983892 BRITEPRO MAX LARYNGOSCOPE CCW FLEXICARE MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Unknown