BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III

    MDR report key: 2453882 · Received January 25, 2012

    Report

    Report Number
    3003496134-2012-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    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

    Additional Manufacturer Narrative · 1

    NEW LOWER APPLIANCE WAS REMADE. (B)(4).

    Description of Event or Problem · 1

    DENTIST CONTACTED AMI AND STATED THAT THE SOCKET BROKE OUT OF THE LOW APPLIANCE. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP III SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. 12TL-00BO-10

    Patients

    Seq Age Sex Outcome Treatment
    1