BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 3955332 · Received July 3, 2014

    Report

    Report Number
    1036445-2014-00005
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED BOUGIE INTRODUCER WAS FOUND TO HAVE BROWN SPOT ON DEVICE AT THE TIME OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391029 ENDOTRACHEAL TUBE INTRODUCER ET TUBE INTRODUCER/BOUGER BSR MEDITEC DEVICES 9-0212-70 MD058

    Patients

    Seq Age Sex Outcome Treatment
    1