BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 570705 · Received January 28, 2005

    Report

    Report Number
    1824231-2005-00001
    Event Type
    Other
    Date Received
    January 28, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE TUB IS APPARENTLY THE WRONG SIZE. CO PUTS THIS TRACH IN THE PT AND HAD TO REMOVE IT AFTER TWO DAYS. THE PT WAS COMPLAINING OF PAIN EVEN WHEN IT WAS DEFLATED. THE PT ALSO EXPERIENCED BLEEDING WHEN USING THIS TRACH. ALSO, THE TIP OF THE TRACH AT THE BOTTOM OF THE WHITE INFLATION LINE HAS A SHARP BARB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CUSTOM MADE TRACHEOSTOMY TUBE BTO SMITHS MEDICAL ASD, INC. * CL36352

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other