BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III ELITE

    MDR report key: 2541841 · Received April 3, 2012

    Report

    Report Number
    3003496134-2012-00005
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 2, 2012
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LOWER APPLIANCE WAS MADE. (B)(4).

    Description of Event or Problem · 1

    DENTIST CONTACTED AMI AND STATED THAT THE LINGUAL BAR BROKE OUT OF THE LOWER APPLIANCE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP III ELITE SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. 3100200-00TV-11

    Patients

    Seq Age Sex Outcome Treatment
    1