BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH MAC

    MDR report key: 19100687 · Received April 12, 2024

    Report

    Report Number
    3010244187-2024-00008
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    November 15, 2023
    Report Date
    April 12, 2024
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    15060272980020
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 REPORTER, EVEN THOUGH IT WAS IMPOSSIBLE TO KNOW WHERE THE TRACHEAL TUBE WAS LOCATED IF IT DID NOT APPEAR IN THE CAMERA FIELD OF VIEW, THE VIDEOLARYNGOSCOPE WAS STILL USE. IN A STATE WHERE A GLOTTIS WAS VISUALIZED DURING THE PROCEDURE, THE TRACHEAL TUBE WAS ADVANCED NASALLY, AND WAS ADVANCED FURTHER WITHOUT THE TIP OF THE TUBE APPEARING IN HANDLE'S FIELD OF VISION, WHICH RESULTED IN PERFORATION OF THE PHARYNGEAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469314 MCGRATH MAC LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000 15060272980020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other