BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY CUFFLESS FENESTRATED

    MDR report key: 2051182 · Received April 6, 2011

    Report

    Report Number
    2936999-2011-00271
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 14, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. RETURN OF THE TUBE FOR INVESTIGATIONS WAS REQUESTED; HOWEVER TO DATE, NO TUBE HAS BEEN RETURNED. IF THE TUBE IS RETURNED FOR INVESTIGATION AND SIGNIFICANT INFO IS IDENTIFIED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS THE FOURTH REPORT OF FIVE, AS FIRST REPORTED IN 2936999-2011-00268.

    Description of Event or Problem · 1

    THE CALLER STATED SHE HAD 5 TRACHEOSTOMY TUBES THAT CRACKED AT THE FLANGE BEFORE THE 29TH DAY REPLACEMENT TIME. THE CALLER STATED SHE IS ON A VENTILATOR ALL THE TIME AND SOMETIMES SHE CAN'T BREATHE AS AIR IS LEAKING AT THE FLANGE END. THE CALLER WHO IS THE PT/USER WAS RECANNULATED PRIOR TO ROUTINE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS FENESTRATED ENDOTRACHEAL TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention