BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 107894 · Received July 25, 1997

    Report

    Report Number
    1217052-1997-00033
    Event Type
    Injury
    Date Received
    July 25, 1997
    Report Date
    June 27, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIMS HAS LIMITED INFO INVOLVING AN EVENT WHERE A TRACHEOSTOMY TUBE ALLEGEDLY BECAME DISLODGED DUE TO IMPROPER PLACEMENT RESULTING IN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE AND TUBE CUFF BTO SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability