BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2190864 · Received July 26, 2011

    Report

    Report Number
    2936999-2011-00501
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    January 12, 2010
    Report Date
    June 28, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE. IF THE SAMPLE IS RETURNED A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS OBTAINED 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 AFTER INSERTION THERE WAS CUFF LEAKAGE. THE TUBE WAS IMMEDIATELY REMOVED AND THE PT WAS RE-CANNULATED WITH 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 1004000418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention