BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED

    MDR report key: 2030533 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00205
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 18, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER PROVIDED WAS FOUND TO BE INVALID AND THEREFORE THE DATE OF MFR CAN NOT BE DETERMINED. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE TRACHEOSTOMY TUBE IS TOO LONG FOR THE PATIENT'S TRACHEA AND THAT THEY WERE TAKING HIM TO THE DOCTOR TO REMOVE THE CURRENT TRACH AND REPLACE IT WITH A NEW TUBE. THE CALLER ALSO STATED THAT THE TRACHEOSTOMY TUBE CURRENTLY IN THE PT HAD BEEN IN PLACE SINCE (B)(6) 2010, WHICH THEY ARE AWARE EXCEEDS THE MFR DIRECTIONS FOR USE OF NO LONGER THAN 29 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE 0709000661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention