BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY 4.0 PED

    MDR report key: 1201496 · Received October 17, 2008

    Report

    Report Number
    2936999-2008-00471
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 22, 2008
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DENT AT 1CM FROM THE TIP OF THE TRACHEOSTOMY TUBE, THEREFORE THE OBTURATOR OR CATHETER COULD NOT BE INSERTED SMOOTHLY. IT WAS REPORTED THAT THE PT WAS RE-INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY 4.0 PED TRACHEOSTOMY TUBE BTO 0802001501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention