BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III

    MDR report key: 2142640 · Received April 29, 2011

    Report

    Report Number
    3003496134-2011-00011
    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
    CT, 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

    AMI WAS CONTACTED THAT A PATIENT USING THE TAP 3 TL APPLIANCE NOTICED THAT THE SOCKET IS OUT OF THEIR LOWER APPLIANCE. 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-00QC-10

    Patients

    Seq Age Sex Outcome Treatment
    1