BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH MAC

    MDR report key: 23723203 · Received December 4, 2025

    Report

    Report Number
    3010244187-2025-00581
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    April 22, 2025
    Report Date
    December 4, 2025
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 LITERATURE SOURCE OF STUDY PERFORMED, A PROSPECTIVE STUDY AIMED TO COMPARE THE EASE AND SUCCESS OF INTUBATION USING A COMPETITOR VERSUS MCGRATH VIDEOLARYNGOSCOPES IN A SIMULATED DIFFICULT AIRWAY. PATIENTS WERE RANDOMLY ALLOCATED TO ONE OF TWO GROUPS COMPRISING 25 PATIENTS. A PHILADELPHIA RIGID CERVICAL COLLAR WAS APPLIED TO ALL PATIENTS BEFORE THE INDUCTION OF ANESTHESIA. COMPLICATIONS INCLUDED DENTAL TRAUMA, BLOOD ON THE LARYNGOSCOPE, AND MINOR INJURIES. THE USAGE OF MCGRATH NECESSITATES GREATER LIFTING POWER AND GREATER APPLICATION OF LARYNGEAL PRESSURE THAN WITH THE COMPETITOR. ARTICLE: A STUDY TO EVALUATE VIDEOLARYNGOSCOPY-GUIDED INTUBATION IN PATIENTS WITH SIMULATED IMMOBILIZED CERVICAL SPINE USING AIRTRAQ AND 1 MCGRATH LARYNGOSCOPES AUTHOR: PRASHANT KUMAR, DEEPAK DAHIYA, KIRANPREET KAUR YEAR: 2025 PUBLICATION: HBKU PRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157844 MCGRATH MAC LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other