BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALBUTEROL INHALER

    MDR report key: 19416178 · Received May 28, 2024

    Report

    Report Number
    MW5155474
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    December 1, 2023
    Report Date
    May 28, 2024
    Manufacturer
    LUPIN PHARMACEUTICALS INC.
    Product Code
    QKS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING SHE HAS HAD PROBLEMS "FOR AT LEAST SIX MONTHS" USING HER ALBUTEROL INHALERS. REPORTER STATES THAT WHEN ATTEMPTING TO USE THE INHALER, SHE IS NOT RECEIVING THE FULL DOSE OF MEDICATION AND HAS TO SQUEEZE THE INHALER MULTIPLE TIMES TO RECEIVE THE PROPER DOSE. REPORTER STATES SHE NEEDS TO HAVE A FUNCTIONING INHALER DUE TO HER BREATHING PROBLEMS. REPORTER STATES "I CALLED THE 1-800 NUMBER ON THE BOX" BECAUSE SHE STATES SHE IS UNABLE TO RETURN THE INHALER TO HER LOCAL PHARMACY FOR REPLACEMENT AFTER SHE HAS USED IT. REPORTER STATES SHE IS FRUSTRATED THAT HER INHALER IS MALFUNCTIONING AND NOT DELIVERING THE CORRECT DOSE OF HER ALBUTEROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258527 ALBUTEROL INHALER INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED QKS LUPIN PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization ALBUTEROL.