BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRITEPRO SOLO SINGLE-USE FIBER OPTIC MINI HANDLE AND BLADE MILLER 1

    MDR report key: 24687021 · Received March 25, 2026

    Report

    Report Number
    24687021
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    January 28, 2026
    Report Date
    March 16, 2026
    Manufacturer
    FLEXICARE MEDICAL LIMITED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BRITEPRO SOLO MILLER 1 W/ MINI HANDLE USED DURING A SIMULATION. PRODUCT WAS IN A SEALED PEDIATRIC RESUSCITATION CART. LIGHT SOURCE NOTED TO BE INOPERABLE. REF 040-02-0410U, LOT 220100681, EXP 2026-12-01. CROSSCHECKED RECALL FROM 2025, THIS MODEL IS LISTED BUT THE LOT # FALL OUTSIDE OF THE RANGE FOR IMPACTED PRODUCT. NOTE THIS IN THE FDA REPORT (FDA RECALL ID Z-2182-2025)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746984 BRITEPRO SOLO SINGLE-USE FIBER OPTIC MINI HANDLE AND BLADE MILLER 1 LARYNGOSCOPE, RIGID CCW FLEXICARE MEDICAL LIMITED 040-02-0410U 220100681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other