BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAP 3 ELITE

    MDR report key: 3012071 · Received March 8, 2013

    Report

    Report Number
    3003496134-2013-00009
    Event Type
    Other
    Date Received
    March 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 8, 2013
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SUSPECTS HIS USE OF THE ORAL APPLIANCE MAY BE CONTRIBUTING TO PAIN AND TICKLING SENSATION IN HIS EARS. WE ARE CURRENTLY ATTEMPTING TO COMMUNICATE WITH HIS DOCTOR. AT THIS TIME A CONCLUSION CANNOT BE MADE.

    Description of Event or Problem · 1

    PATIENT REPORTED VIA EMAIL THAT HE HAD BEEN EXPERIENCING SOME PAIN AND A TICKLING SENSATION IN HIS EARS, AND HE SUSPECTED THAT HIS USE OF OUR ORAL APPLIANCE MAY HAVE CONTRIBUTED TO THE ISSUE. THE PATIENT HAS BEEN USING HIS ORAL APPLIANCE FOR APPROXIMATELY 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100396 TAP 3 ELITE SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. T3TLL-0BDP-12

    Patients

    Seq Age Sex Outcome Treatment
    1