BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KING LT OROPHARYNGEAL AIRWAY

    MDR report key: 566614 · Received December 27, 2004

    Report

    Report Number
    MW1034336
    Event Type
    Malfunction
    Date Received
    December 27, 2004
    Report Date
    December 22, 2004
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER OF INSTRUMENT TRAYS ARE PROVIDING UNACCEPTABLE STERILIZATION INSTRUCTIONS FOR STANDARD HOSPITAL STERILIZATION CYCLES. SOME COMPANIES ARE NOT ABLE TO PROVIDE STERILIZATION INSTRUCTIONS IN WRITING WHEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *