BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP 1

    MDR report key: 2881238 · Received November 12, 2012

    Report

    Report Number
    3003496134-2012-00029
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 13, 2012
    Manufacturer
    AIRWAY MANAGEMENT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K061732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO HER DENTIST THAT THE HARDWARE OF THE UPPER TRAY OF HER ORAL APPLIANCE HAD COME LOOSE. THERE WAS NO HARM TO THE PT. THE DEVICE WAS REPAIRED AND RETURNED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP 1 SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT, INC. 08T-0AOQ-12

    Patients

    Seq Age Sex Outcome Treatment
    1