BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III

    MDR report key: 2541838 · Received April 3, 2012

    Report

    Report Number
    3003496134-2012-00007
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 6, 2012
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOOK WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    DENTIST CONTACTED AMI AND STATED THAT THE TAP 3 HOOK BROKE ON THE UPPER APPLIANCE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP III SLEEP APNEA DEVICE LRK AIRWAY MANAGEMENT INC. 12K-00VJ-09

    Patients

    Seq Age Sex Outcome Treatment
    1