BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP 3 ELITE

    MDR report key: 2851358 · Received October 30, 2012

    Report

    Report Number
    3003496134-2012-00027
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 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 LINGUAL BAR OF HIS ORAL APPLIANCE HAD BROKEN. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS REPAIRED AND RETURNED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP 3 ELITE SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. 3100-0BCF-12

    Patients

    Seq Age Sex Outcome Treatment
    1