BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 21724885 · Received March 28, 2025

    Report

    Report Number
    9681384-2025-00310
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    October 25, 2024
    Report Date
    March 28, 2025
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KAI SU, SHANGJUN XU, HAIXIA WANG, XINTAO LI, FUSHAN XUE, MING TIAN, DEPARTMENT OF ANAESTHESIOLOGY, BEIJING FRIENDSHIP HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING 100050, CHINA; DEPARTMENT OF ANAESTHESIOLOGY, BEIJING PINGGU HOSPITAL, BEIJING 101200, CHINA, SUBGLO TTIC AIRWAY INJURY DURING FIBERSCOPE-MONITORED INTUBATION WITH A SUPRAGLOTTIC AIRWAY DEVICE: A RANDOMIZED CONTROLLED COMPARISON OF THREE TRACHEAL TUBES, CHINESE MEDICAL JOURNAL 2025;138(3, WWW.CMJ.ORG, PAGES 343-345 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A TRIAL WAS DESIGNED TO COMPARE THE SUBGLOTTIC AIRWAY INJURY CAUSED BY PVC, REINFORCED, AND A COMPETITOR TRACHEAL TUBE DURING FIBEROPTIC-MONITORED INTUBATION THROUGH A SUBGLOTTIC AIRWAY DEVICE. A PVC TUBE, A FLEXIBLE REINFORCED TRACHEAL TUBE AND A COMPETITOR TUBE WERE USED. COMPLICATIONS IN THE PVC GROUP INCLUDED SUBGLOTTIC AIRWAY INJURY WITH A SCORE OF 5.0 (2.0-9.0). THE ARTICLE STATES ¿THE BLOCKBUSTER AND REINFORCED TRACHEAL TUBES WERE ASSOCIATED WITH SIGNIFICANTLY LESS SEVERE SUBGLOTTIC AIRWAY INJURY THAN WAS THE PVC TRACHEAL TUBE. NO INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649755 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH COVIDIEN AG JUAREZ (MMJ) UNKNOWN SHILEY TRACH TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other