BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III ELITE

    MDR report key: 2823584 · Received October 8, 2012

    Report

    Report Number
    3003496134-2012-00023
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 8, 2012
    Manufacturer
    AIRWAY MANAGEMENT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO HIS DENTIST THAT A PIECE OF THE ACRYLIC SHELF OF THE LOWER TRAY OF HIS ORAL APPLIANCE BROKE OFF. THERE WAS NO HARM TO THE PT. A REPLACEMENT DEVICE FABRICATED AND SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP III ELITE SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT, INC. TAP3100-0BIY-12

    Patients

    Seq Age Sex Outcome Treatment
    1