BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DCT

    MDR report key: 1024364 · Received April 2, 2008

    Report

    Report Number
    2936999-2008-00149
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    HENEQUEN
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN IS MAKING ATTEMPTS TO CONFIRM THE SHILEY 6DCT WAS REMOVED FROM THE PT AND IF AVAILABLE TO BE RETURNED FOR FAILURE INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE TUBE IS RETURNED OR ANY NEW SIGNIFICANT INFO IS OBTAINED. A MFG CAPA IS ALREADY IN PLACE TO ADDRESS CUFF LEAKS.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A SHILEY 6DCT TRACHEOSTOMY TUBE WAS LEAKING WHILE IN A PT. HE REPORTED THAT HE INTENDED TO REMOVE THE TUBE. THE DOCTOR DID NOT KNOW THE LOT NUMBER OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DCT TRACHEOSTOMY TUBE BTO HENEQUEN DCT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR