BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOUGIE

    MDR report key: 3866663 · Received June 5, 2014

    Report

    Report Number
    MW5036489
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SUNMED
    Product Code
    FAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOUGIE INTRODUCER TUBE USED FOR INTUBATION. AFTER WAS USED IN THE PATIENT'S MOUTH, APPROX AT THE 27 CM MARK THERE WAS A BROWN MARK THAT CORRESPONDING TO A BROWN MARK IN THE STERILE WRAPPER. THE TUBE WAS PLACED IN THE PATIENT'S MOUTH TO THE 23 CM MARK. NO PATIENT HARM DETECTED. DIAGNOSIS OR REASON FOR USE: ENDOTRACHEAL INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328832 BOUGIE INTRODUCER FOR ADULT ENDOTRACHEAL INTUBATION FAX SUNMED 9-0212-70 MD058

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR