BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTOLIN HFA INH 18GM W/COUNT; 90MCG

    MDR report key: 2310331 · Received October 20, 2011

    Report

    Report Number
    MW5022808
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    June 11, 2011
    Report Date
    October 17, 2011
    Manufacturer
    GSK
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PER PATIENT, NO MEDICATION COMES OUT OF DEVICE EVEN AFTER FOLLOWING PROPER CLEANING INSTRUCTIONS. DOSE, FREQUENCY AND ROUTE USED: INHALE 2 PUFFS EVERY 4 HOURS AS NEEDED. THERAPY DATES: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTOLIN HFA INH 18GM W/COUNT; 90MCG INHALER CCQ GSK 1ZP1198

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR