BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 1061843 · Received June 13, 2008

    Report

    Report Number
    1061843
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MALLINCKRODT HEALTHCARE
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS IS A MALE PT THAT UNDERWENT TRACHEOSTOMY IN 2008, AND TWO WEEKS LATER THE TRACHEOSTOMY TUBE HAD TO BE REPLACED FOLLOWING BREAKAGE OF DEVICE AT THE NECK LEVEL. THE PRETRACHEAL TISSUES HAD TO BE REDISSECTED AND THE TRACHEAL OPENING HAD TO BE DILATED IN ORDER TO REPLACE THE BROKEN TRACHEOSTOMY TUBE. A PICTURE OF THE BROKEN TRACHEOSTOMY TUBE IS ATTACHED TO THIS FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE BTO MALLINCKRODT HEALTHCARE LPC *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention