BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III ELITE

    MDR report key: 2783993 · Received October 1, 2012

    Report

    Report Number
    3003496134-2012-00021
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    AIRWAY MANAGEMENT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED TO HIS DENTIST THAT THE HOOK OF HIS ORAL APPLIANCE HAD BROKEN LOOSE FROM THE UPPER TRAY. THERE WAS NO HARM TO THE PATIENT. INVESTIGATION SHOWED EVIDENCE THAT THE PATIENT HAD BITTEN DOWN ONTO THE LOWER TRAY, PUTTING EXCESSIVE FORCE ON THE HOOK. THE REPLACEMENT DEVICE FABRICATED AND SENT 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. TAP3100-0BMQ-12

    Patients

    Seq Age Sex Outcome Treatment
    1