BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRACH CARE TRAY STANDARD

    MDR report key: 634236 · Received September 12, 2005

    Report

    Report Number
    9612030-2005-00021
    Event Type
    Death
    Date Received
    September 12, 2005
    Date of Event
    March 31, 2005
    Report Date
    September 12, 2005
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    LRQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER EXPERIENCED A PROBLEM WITH THE BRUSH A THE TRACHEOSTOMY CARE TRAY. THE CUSTOMER SATES "WHILE USING THE TRACHEOSTOMY BRUSH THAT WAS INCLUDED IN THE TRACHEOSTOMY CARE TRAY TO CLEAN THEIR TRACHEA, THE BRUSH BECAME DISLODGED FROM ITS PLASTIC HANDLE AND OBSTRUCTED THEIR AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE TRAY STANDARD TRACHEOSTOMY BRUSH LRQ TYCO/KENDALL HEALTHCARE 47800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death