BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1790765 · Received August 3, 2010

    Report

    Report Number
    2936999-2010-01042
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 9, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRACHEOSTOMY TUBES CUFF BECAME HARD AND CAUSED BLEEDING IN THE PT. THE TUBE WAS REMOVED AND THE PT WAS RE CANNULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1001000925

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention