BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUTEROL HFA INHALER

    MDR report key: 19382455 · Received May 22, 2024

    Report

    Report Number
    MW5155284
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Report Date
    May 22, 2024
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED STATING SHE IS HAVING ISSUES WITH THE DELIVERY. WHEN SHE PUSHES DOWN THE COUNTER MOVES AND THE INDICATOR IS READING ZERO BUT THERE IS STILL MEDICATION IN THE CANISTER. SHE STATES THERE ALSO SEEMS TO BE A CONTAINER DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300038 ALBUTEROL HFA INHALER NEBULIZER (DIRECT PATIENT INTERFACE) CAF GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female