BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH INDUSTRIES MEDICAL SYSTEMS

    MDR report key: 114756 · Received August 22, 1997

    Report

    Report Number
    114756
    Event Type
    Injury
    Date Received
    August 22, 1997
    Date of Event
    July 15, 1997
    Report Date
    August 19, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PERFORATION OF TRACHEA (POSTERIOR WALL) AFTER PLACEMENT OF PRECUTANEOUS TRACHEOSTOMY TUBE (RECOGNIZED WITHIN MINUTES OF PLACEMENT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH INDUSTRIES MEDICAL SYSTEMS Implant PERCUTANEOUS TRACHEOSTOMY #9 BTO SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 9MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening CERVICAL (NECK) SPINE FIXATION HARDWARE| IMPLANTED 2 WEEKS EARLIER.