BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 23312797 · Received October 16, 2025

    Report

    Report Number
    MW5177459
    Event Type
    Injury
    Date Received
    October 16, 2025
    Report Date
    October 10, 2025
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT HER CURRENT TUBING/MOUTHPIECE LOOKS DISCOLORED AND SHE REQUESTED A REPLACEMENT. NO MISSED DOSE OR ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252339 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female OHTUVAYRE INH SUSP