BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINHALER

    MDR report key: 18447007 · Received January 3, 2024

    Report

    Report Number
    MW5149792
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 3, 2024
    Manufacturer
    LUPIN PHARMACEUTICALS INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED WITH COMPLAINT THAT HER LUPINHALER DEVICE IS MALFUNCTIONING. THE DEVICE WILL NOT DELIVER MEDICATION AND IT WILL NOT OPEN TO ENABLE INSERTION OF NEW CAPSULES (TIOTROPIUM BROMIDE POWDER) FOR DELIVERY OF MEDICATION. ADDITIONALLY, THE CAPSULE PACKAGING IS EXTREMELY DIFFICULT TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507371 LUPINHALER NEBULIZER (DIRECT PATIENT INTERFACE) CAF LUPIN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other