BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIC TRACHEOSTOMY TUBE

    MDR report key: 181122 · Received August 7, 1998

    Report

    Report Number
    1217052-1998-00040
    Event Type
    Malfunction
    Date Received
    August 7, 1998
    Date of Event
    July 1, 1998
    Report Date
    July 10, 1998
    Manufacturer
    SIMS PORTEX, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT RETURNED TO THE REHABILITAION FACILITY WITH HER TRACHEOSTOMY TUBE INTACT. A FEW HOURS LATER, A NURSE ALLEGEDLY NOTICED THE PILOT BALLOON OF THE TRACHEOSTOMY TUBE LAYING ON THE FLOOR. THE TRACHEOSTOMY TUBE WAS REPLACED WITHOUT CONSEQUENCE. THE DURATION OF TRACHEOSTOMY TUBE USE PRIOR TO THIS EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE AND TUBE CUFF BTO SIMS PORTEX, INC. NA 703364

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR