BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOVENT ACTUATOR MCG 110

    MDR report key: 13417886 · Received January 31, 2022

    Report

    Report Number
    MW5107109
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    September 1, 2021
    Report Date
    February 23, 2022
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 2/23/2022 FOR REPORT MW5107109. REPORTER STATED THAT ONE PERSON HAVING A PROBLEM WITH THEIR DEVICE SHOULD BE ENOUGH FOR THE FDA TO MAKE CHANGES.

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT A PRODUCT ISSUE WITH HER INHALER. PATIENT STATED SHE NOTICED AROUND EARLY (B)(6) THAT SHE WAS UNABLE TO REMOVE THE CAP, IT WAS TOO DIFFICULT FOR HER TO GET OFF BY HERSELF AND SHE REQUIRED THE HELP OF HER HUSBAND. PATIENT STATED IT WOULD BE A BETTER DESIGN IF THE CAP COULD BE ATTACHED INSTEAD WHICH WOULD ALSO HELP WITH THE RISK OF IT FALLING AND BECOMING DIRTY. PATIENT STATED SHE HOPES THIS GETS LOOKED INTO ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561821 FLOVENT ACTUATOR MCG 110 NEBULIZER (DIRECT PATIENT INTERFACE) CAF GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC FP8P

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other