BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROBIKA

    MDR report key: 7746714 · Received August 2, 2018

    Report

    Report Number
    MW5078849
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    July 22, 2018
    Report Date
    July 31, 2018
    Manufacturer
    TRUDELL MEDICAL INT'L
    Product Code
    BWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE GREEN VALVE OF MY CHILD'S AEROBIKA CAME OUT AND WAS LODGED IN HER AIRWAY WHILE SHE WAS USING IT. SHE WAS CHOKING AND FORTUNATELY WAS ABLE TO COUGH HARD ENOUGH TO GET THE PART OUT. THIS PART IS LARGE ENOUGH TO COMPLETELY BLOCK AN AIRWAY AND BECOME DEADLY. THIS IS NOT THE FIRST TIME WE HAVE HAD A PROBLEM WITH THE VALVE IN MORE THAN ONE AEROBIKA. AS A PARENT AND A PEDIATRIC NURSE, I FIND THIS VERY TROUBLING AND FELT OBLIGATED TO REPORT THIS ISSUE. THIS PROBLEM WAS REPORTED TO MONAGHAN AND THEY HAVE SENT REPLACEMENTS BUT THEY WANT THE DEFECTIVE DEVICE BACK. I DON'T' KNOW IF I SHOULD GIVE IT TO THEM OR HOLD ONTO IT FOR NOW. MONAGHAN MEDICAL CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586543 AEROBIKA SPIROMETER, THERAPEUTIC (INCENTIVE) BWF TRUDELL MEDICAL INT'L 180011

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening