BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP 3

    MDR report key: 3049688 · Received March 14, 2013

    Report

    Report Number
    3003496134-2013-00010
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 13, 2013
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO HIS DENTIST THAT THE SOCKET OF HIS ORAL APPLIANCE HAD BROKEN OFF. THERE WAS NO HARM TO THE PT. THE DEVICE WAS REPAIRED BY REMAKING THE LOWER TRAY, AND RETURNED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108667 TAP 3 SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. 12TL-0BSB-12

    Patients

    Seq Age Sex Outcome Treatment
    1