BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY 5.0PED

    MDR report key: 1210509 · Received October 22, 2008

    Report

    Report Number
    2936999-2008-00487
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 29, 2008
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER PROVIDED IS INCOMPLETE OR INCORRECT. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. RETURN OF TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. 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 THE PRODUCT WAS PLACED IN PT'S AIRWAY AFTER PROBLEMS WITH ANOTHER SIMILAR TRACHEOSTOMY TUBE. IT WAS REPORTED THAT "LATER THAT EVENING WHEN THE PT WAS PLACED ON HER VENTILATOR A LEAK WAS NOTICED; HARD TO VENTILATE; LOOKED AT THE TRACHEOSTOMY TUBE AND NOTICED IT WAS BROKEN JUST BELOW THE FLANGE." IT WAS REPORTED "NOTED BY MOTHER OF FEMALE PT IN THE PT'S HOME; IN USE 3-4 HOURS." IT WAS REPORTED "PT STATUS REPORTED AS FULL RECOVERY; NO INJURY; THE TRACHEOSTOMY TUBE REPLACED WITH A NEW ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY 5.0PED TRACHEOSTOMY TUBE BTO 211402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention