BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP 1

    MDR report key: 3003470 · Received February 11, 2013

    Report

    Report Number
    3003496134-2013-00005
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 11, 2013
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 OFF. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS REPAIRED BY REMAKING THE LOWER TRAY, AND RETURNED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60405 TAP 1 SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. 02-00NK-11

    Patients

    Seq Age Sex Outcome Treatment
    1