BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC PLUS AEROSOL DELI

    MDR report key: 21344010 · Received February 10, 2025

    Report

    Report Number
    MW5165806
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Report Date
    January 23, 2025
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC./PRE HOLDING, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED UNSOLICITED COMMUNICATION FROM PATIENT REPORTING THE MEDICATION CUP IS CLOGGED AND ALTHOUGH HE IS WASHING IT AS DIRECTED THE CUP CONTINUES TO BE CLOGGED. NO MISSED DOSE OR ADVERSE REPORTED; UNKNOWN IF AVAILABLE FOR RETURN; UNKNOWN IF MD AWARE. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960725 VIOS LC PLUS AEROSOL DELI NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC./PRE HOLDING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male