BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRITE PRO SOLO

    MDR report key: 22938320 · Received September 2, 2025

    Report

    Report Number
    3006061749-2025-00045
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 2, 2025
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    CCW
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO INDIRECT HARM WAS REPORTED. NO REPORT OF HOSPITALIZATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE-THREATENING. NO DEATH REPORTED. REPORTED AS REQUIRING INTERVENTION TO PREVENT PERMANENT DAMAGE. THIS IS A REPORT IN RESPONSE TO THE INITIAL REPORT SUBMITTED TO THE FDA BY THE COMPLAINANT MW5171679 AND TO THE REPORT WE SUBMITTED ON THE 5TH AUGUST 2025 3006061749-2025-00028.

    Description of Event or Problem · 0

    NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF HOSPITALISATION - INTIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. N0 DEATH REPORTED. NOT REPORTED AS REQUIRING INTERVENTION TO PREVENT PERMANENT DAMAGE. THIS REPORT IS SUBSEQUENT TO THE CUSTOMER REPORT TO THE FDA AND OUR REPORT DATED 5TH AUGUST 2025 REF 3006061749-2025-00028. "SPOT CHECKING CONDUCTED FOUND 3 OF 5 BLADES TESTED FAILED WITH 2 NOT LIGHTING AND 1 DIM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086759 BRITE PRO SOLO LARYNGOSCOPE VIDEO CCW FLEXICARE MEDICAL LTD 200902793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown