BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH MAC 4 DISPOSABLE LARYNOGOSCOPE BLADE

    MDR report key: 10301755 · Received July 20, 2020

    Report

    Report Number
    MW5095629
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    May 21, 2020
    Report Date
    July 17, 2020
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED FOR A SURGICAL PROCEDURE WITH A MCGRATH MAC 4 BLADE. POST PROCEDURE IN PACU PATIENT APPEARED CONGESTED AND COUGHED A LOT. NURSE ASSESSED ORAL CAVITY AND NOTICED A PLASTIC FOREIGN BODY. NURSE REMOVED FOREIGN BODY AND IT WAS DISCOVERED TO BE A MAC 4 DISPOSABLE LARYNGOSCOPE BLADE. ONCE REMOVED, PATIENT CONDITION IMPROVED AND WAS DISCHARGE FOR AREA. PATIENT'S ANESTHESIOLOGIST AND SURGEON WERE BOTH MADE AWARE OF THE EVENT. PATIENT HAD NO ADDITIONAL COMPLAINTS OTHER THAN A SORE THROAT IN THE POST OP CALL. CONCERN FOR CENTER STAFF WAS THE BLADE DOES NOT FULLY SECURE ON THE LARYNGOSCOPE. THIS INCREASES RISK OF LEAVING DISPOSABLE BLADE IN ORAL CAVITY POST INTUBATION. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757990 MCGRATH MAC 4 DISPOSABLE LARYNOGOSCOPE BLADE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 350-012-000 P19040102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention