BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY TRACHEOSTOMY TUBE (CFN)

    MDR report key: 130313 · Received November 3, 1997

    Report

    Report Number
    130313
    Event Type
    Death
    Date Received
    November 3, 1997
    Date of Event
    August 14, 1997
    Report Date
    August 27, 1997
    Manufacturer
    MALLINCKRODT, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RESIDENT WAS RETURNED TO BED AND POSITIONED BY THE NURSING STAFF AND HER MOTHER JUST PRIOR TO 3:00 PM ON 8/14/97. THE RESIDENT WAS CHECKED ON BY A NURSING ASSISTANT AT 3:45 PM. AT THAT TIME, SHE WAS FINE. THE RESIDENT WAS CHECKED ON AGAIN AT 4:15 PM. THE RESIDENT HAD EXPIRED. WHEN ASSESSED AT 4:20 PM, THE RESIDENT'S FACE WAS PALE BUT HER LIPS WERE CYANOTIC. THERE WAS NO APICAL OR RADIAL PULSE. FRESH MUCOUS WAS FOUND ON HER NIGHTSHIRT, SEEMING THAT SHE HAD COUGHED OR SNEEZED. HER HEAD HAD FALLEN FORWARD, AND THE LEFT SIDE OF HER NECK COVERED THE TRACHEOSTOMY WHICH EXTENDED OFF HER NECK 1-1.5".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE (CFN) Implant CUFFLESS FENESTRATED TRACHEOSTOMY TUBE BTO MALLINCKRODT, INC. 6 CFN M50196000

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death