BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    040-341U BRITEPRO SOLO SINGLE-USE FIBER OPTIC HANDLE AND BLADE MILLER 1

    MDR report key: 22554778 · Received July 21, 2025

    Report

    Report Number
    3006061749-2025-00020
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    September 13, 2023
    Report Date
    July 21, 2025
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    UDI-DI
    05055788724063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERIOUS INJURY/HARM TO PATIENT OR USER REPORTED. NO INDIRECT HARM REPORTED. NO REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE REPORTED. NO HOSPITALIZATION - INTIAL OR STAY PROLONGED BY 1 DAY OR MORE REPORTED. NO SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT REPORTED. NOT REPORTED AS LIFE THREATING. NO DEATH REPORTED. THIS WAS INFORMED BASED ON MAUDE DATABASE BUT COULD NOT BE LOCATED ON MAUDE DATABASE THEREFORE THIS IS A REPORT FOR A CUSTOMER REPORT THAT MAY NOT EXUST BUT AS SUCH WE ARE PRECAUTIONARILY REPORTING IT.

    Description of Event or Problem · 0

    THE BLADE LIGHT FAILED WHEN CHECKED PRIOR TO USE ON PATIENT NO PATIENT HARM OR RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731851 040-341U BRITEPRO SOLO SINGLE-USE FIBER OPTIC HANDLE AND BLADE MILLER 1 LARYRNGOSCOPE CCW FLEXICARE MEDICAL LTD 190402252 05055788724063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown