BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULIZER PARI PLUS LC

    MDR report key: 23544298 · Received November 12, 2025

    Report

    Report Number
    MW5178822
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Report Date
    November 10, 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

    INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED; PATIENT REPORTED HAVING ISSUES WITH THE NEBULIZER, THE CAP WASN'T CLOSING. PATIENT DID NOT REPORT ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140101 BULIZER PARI PLUS LC NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female OHTUVAYRE INH SUSP