BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE WITH HYPER ANGULATED BLADE SIZE 3.5

    MDR report key: 23754472 · Received December 9, 2025

    Report

    Report Number
    3006061749-2025-00061
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 8, 2025
    Manufacturer
    FLEXICARE MEDICAL LTD.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WENT TO INTUBATE PATIENT AND BLADE WOULD NOT PROPERLY CONNECT TO MONITOR AND VIDEO WOULD GO OUT. NO SERIOUS INJURY/HARM TO PATIENT. NO INDIRECT HARM. NO REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT LIFE THREATENING. NO DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114761 PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE WITH HYPER ANGULATED BLADE SIZE 3.5 PROVU SINGLE USE VIDEO LARYNGOSCOPE HANDLE WITH HYPER ANGULATED BLADE SIZE 3.5 BTR FLEXICARE MEDICAL LTD. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown