BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3030024 · Received March 27, 2013

    Report

    Report Number
    3030024
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 27, 2013
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    THE BRIDGE OVER THE TOP LIP SPONGE PART OF THE HOLLISTER ORAL ENDOTRACHEAL TUBE ATTACHMENT DEVICE CAME LOOSE AND WAS FOUND IN THE THROAT OF THE PATIENT. IT DID NOT APPEAR TO BE BLOCKING ANYTHING AND WAS NOT SWALLOWED AS PATIENT WAS SEDATED. THE SPONGE WAS NOTED DURING ORAL CARE AND REMOVED WITH LONG FORCEPS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ENDOTRACHEAL TUBE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125909 * DEVICE, FIXATION, TRACHEAL TUBE CBH HOLLISTER INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR