BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP II

    MDR report key: 2171422 · Received October 2, 2006

    Report

    Report Number
    3003496134-2006-00001
    Event Type
    Malfunction
    Date Received
    October 2, 2006
    Date of Event
    September 27, 2006
    Report Date
    September 28, 2006
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS INSTRUCTED TO CONTACT HER PRESCRIBER FOR FURTHER INSTRUCTIONS. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    PT COMPLAINED THAT DURING THE NIGHT SHE SWALLOWED PART OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP II TAP II LRK AIRWAY MANAGEMENT INC. 11 00KX-05

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other