BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PERCUTANEOUS

    MDR report key: 2251323 · Received September 13, 2011

    Report

    Report Number
    2936999-2011-00574
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    PMA / PMN Number
    K884730
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE THE DATE OF MANUFACTURE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED STATED THE THORACIC SURGEONS ATTEMPTED TO INSERT A SIZE 8 PERC TRACH INITIALLY. UNABLE TO INSERT DUE TO SCAR TISSUE. TRIED SIZE 6 PERC TRACH AND THEY NOTICED THAT THE OBTURATOR/DILATOR WAS NOT FITTING WELL AND WHEN THEY LOOKED AT IT THEY NOTICED THE TIP. THE PT WAS RECANNULATED WITH ANOTHER UNSPECIFIED TRACH TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PERCUTANEOUS TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention