BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2120134 · Received June 3, 2011

    Report

    Report Number
    2936999-2011-00313
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVAL. WITHOUT THE ACTUAL COMPLAINT SAMPLE BEING RETURNED, A FULL INVESTIGATION CANNOT BE CARRIED OUT. THE LOT # HAS BEEN PROVIDED SO A LOT HISTORY REVIEW WILL BE PERFORMED. IF THE SAMPLE IS RECEIVED AT A LATER DATE AND/OR IF SIGNIFICANT INFO BECOMES AVAILABLE RELATED TO THIS REPORT, A SUMMARY WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. INFO HAS BEEN ADDED TO DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE BALLOON CAME OFF THE CANNULA AND THE PT WAS RECANNULATED THE NEXT DAY AT THE HOSP. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY XLT EXTENDED-LENGTH TRACHEOSTOMY TU JOH COVIDIEN, FORMERLY TYCOHEALTHCARE 2010113653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention