BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTRACHEAL SYSTEMS

    MDR report key: 241018 · Received September 15, 1999

    Report

    Report Number
    MW1017178
    Event Type
    Malfunction
    Date Received
    September 15, 1999
    Date of Event
    September 14, 1999
    Report Date
    September 14, 1999
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Product Code
    KCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PREPPED FOR TRANSTRACHEAL OXYGEN DEVICE PLACEMENT. KIT DID NOT CONTAIN TRANSTRACHEAL OXYGEN STENT. SCOOP TUBE #9 WAS USED AFTER TRIMMING EXTERNAL TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSTRACHEAL SYSTEMS SCOOP PROCEDURE TRAY KCG TRANSTRACHEAL SYSTEMS T-9 0339

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR