BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FLEXIBLE TRACH TUBE

    MDR report key: 18606988 · Received January 29, 2024

    Report

    Report Number
    MW5150875
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 25, 2024
    Report Date
    January 25, 2024
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EMERGENCY TRACH CHANGE DONE DUE TO LOSS IN TIDAL VOLUMES. LEAK NOTED IN CUFF. OLD TRACH WAS REMOVED AND NEW TRACH, (B)(4), WAS INSERTED WITH NO BLEEDING FROM THE SITE (B)(6) 2024 ; 23:45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252062 SHILEY FLEXIBLE TRACH TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention