BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 23341768 · Received October 20, 2025

    Report

    Report Number
    MW5177655
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Report Date
    October 15, 2025
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS THAT THERE IS A FLAP MISSING ON HER VIOS LC AEROSOL DELIVERY SYSTEM. PATIENT IS UNSURE WHAT HAPPENED TO THE FLAP. NO MISSED DOSE OR ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451598 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female OHTUVAYRE INH SUSP INHALATION SUSPENSION.