BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN CHECK DIAL

    MDR report key: 5495439 · Received March 9, 2016

    Report

    Report Number
    MW5060842
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    February 24, 2016
    Report Date
    February 28, 2016
    Manufacturer
    ALLIANCE TECH MEDICAL, INC.
    Product Code
    BYP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    SUBJECT PARTICIPATING IN (B)(6). DURING VISIT, SUBJECT WAS TO COMPLETE PIFR TEST PER PROTOCOL. WHEN SUBJECT TOOK INHALATION BREATH WITH DEVICE IN MOUTH, CIRCULAR VALVE ON ATTACHMENT BECAME DETACHED AND WAS SUCKED INTO SUBJECT'S THROAT. SUBJECT WAS ABLE TO COUGH TO BRING PIECE OUT OF MOUTH. MANUFACTURER AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147224 IN CHECK DIAL IN CHECK DIAL BYP ALLIANCE TECH MEDICAL, INC. 79058
    147225 INSPIRATORY INSPIRATORY BYP ALLIANCE TECH MEDICAL, INC. 3122069 REVOL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR