BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT

    MDR report key: 120707 · Received September 18, 1997

    Report

    Report Number
    1217052-1997-00037
    Event Type
    Injury
    Date Received
    September 18, 1997
    Date of Event
    May 2, 1997
    Report Date
    August 19, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH A BRAIN HEMORRHAGE AND RESPIRATORY FAILURE UNDERWENT THE PERCUTANEOUS TRACHEOSTOMY PROCEDURE AND EXPERIENCED A POSTERIOR LACERATION OF THE TRACHEAL WALL RESULTING IN A PNEUMOTHORAX. THE PT UNDERWENT A THORACOTOMY AND SURGICAL REPAIR OF THE TRACHEAL LACERATION. THE PT DID NOT EXPERIENCE ANY LONG TERM EFFECTS FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT TRACHEOSTOMY TUBE AND TUBE CUFF BTO SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 612478

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening