BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 23647612 · Received November 25, 2025

    Report

    Report Number
    MW5179430
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Report Date
    November 20, 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

    PT REPORTED THAT A PIECE OF THE NEBULIZER THAT ATTACHES TO THE VALVE CAP HAS BROKEN OFF OF THE NEBULIZER AND NEEDS TO BE REPLACED OR AN ENTIRE NEW UNIT NEEDS TO BE SENT. NO MISSED DOSES OR ADVERSE EVENTS REPORTED. NO OTHER INFORMATION PROVIDED. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265294 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC. 310F83-LC AD25G00973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male OHTUVAYRE INH SUSP