BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III

    MDR report key: 2142642 · Received April 29, 2011

    Report

    Report Number
    3003496134-2011-00012
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AIRWAY MANAGEMENT, INC
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AMI HAS REPAIRED THE APPLIANCE AND REPLACED THE LOWER TRAY. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    DENTIST CONTACTED AMI AND STATED THAT THE LOWER HARDWARE LOOSENED AND THE SOCKET CAME OUT OF THE LOWER APPLIANCE AND THE PATIENT ALMOST SWALLOWED THE SOCKET. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP III SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT, INC 12TL-00FD-11

    Patients

    Seq Age Sex Outcome Treatment
    1