BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KING SYSTEMS

    MDR report key: 483011 · Received September 4, 2003

    Report

    Report Number
    MW1029452
    Event Type
    Malfunction
    Date Received
    September 4, 2003
    Date of Event
    August 28, 2003
    Report Date
    September 4, 2003
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KING LT OROPHARYNGEAL AIRWAY SIZE #4 INSERTED BY PHYSICIAN AT TIME OF INDUCTION. RED TIP AT DISTAL END OF AIRWAY FLAKED AWAY. AIRWAY WAS REMOVED ALONG WITH THE PIECE THAT BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KING SYSTEMS KING LT OROPHARYNGEAL AIRWAY CAE KING SYSTEMS CORP. SIZE #4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR