BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEREVENT DISKUS

    MDR report key: 463088 · Received June 3, 2003

    Report

    Report Number
    MW1028575
    Event Type
    Death
    Date Received
    June 3, 2003
    Date of Event
    September 20, 2002
    Report Date
    June 3, 2003
    Manufacturer
    GLAXO SMITH AND KLINE
    Product Code
    CCQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT PASSED AWAY SUDDENLY AFTER HAVING USED INHALER 3 HOURS EARLIER FOR PREVENTION OF EXERCISED INDUCED ASTHMA. FAMILY MEMBER THINKS THE INHALER DELIVERED TOO MUCH MEDICATION BECAUSE THE DOSES LEFT WERE 22 OUT OF A 60 DOSE CONTAINER. PT HAD ONLY USED IT FOR 18 DAYS. THE DAY BEFORE, THEY HAD COMPLAINED ABOUT FEELING "PIECES IN IT". FAMILY MEMBER THINKS IT WAS CLICKING TWICE AND THE COUNTER WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEREVENT DISKUS INHALER-USED FOR ASTHMA MEDICATION CCQ GLAXO SMITH AND KLINE * BO65306

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death