BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2030664 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00219
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 1, 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
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. 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 CUSTOMER REPORTED THAT THE TRACHEOSTOMY TUBE WAS INSERTED INTO THE PT AND THE CUFF BECAME OVAL. THE TUBE WAS REMOVED AND THE PT WAS RE CANNULATED WITH A NEW TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 1006002340

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention