BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP III

    MDR report key: 2192760 · Received June 9, 2011

    Report

    Report Number
    3003496134-2011-00023
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AMI HAS REPAIRED THE APPLIANCE. A CAPA INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    DENTIST CONTACTED AMI AND STATED THAT THE UPPER BASE PLATE BROKE OFF THE UPPER 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-00EG-11

    Patients

    Seq Age Sex Outcome Treatment
    1