BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INHALER

    MDR report key: 19938789 · Received August 7, 2024

    Report

    Report Number
    MW5158139
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    LUPIN PHARMACEUTICALS INC.
    Product Code
    KCO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A REPORT ABOUT THE DEFECTIVE INHALERS HE IS USING FROM LUPIN. HE SAID HE HAS BEEN USING INHALERS FOR SO LONG FOR HIS ASTHMA, BUT THE LUPIN INHALERS DO NOT WORK. HE SAID WHEN HE DEPRESSES THE EQUIPMENT NOTHING COMES OUT. HE SAID HE ALMOST DIED LAST NIGHT FROM ASTHMA ATTACK BECAUSE THE INHALER DID NOT WORK. HE SAID AT LEAST 10 OF THEM FAILED. REFERENCE REPORTS: #MW5158133, #MW5158134, #MW5158135, #MW5158136, #MW5158137, #MW5158138, #MW5158140, #MW5158141, #MW5158142.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294746 INHALER NASAL SPRAY, ENT DELIVERY KCO LUPIN PHARMACEUTICALS INC. IA00269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening