BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED TRACH

    MDR report key: 2890548 · Received December 20, 2012

    Report

    Report Number
    2936999-2012-00693
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. APPLICABLE 510K CANNOT BE CONFIRMED SINCE PRODUCT ID IS UNK.

    Description of Event or Problem · 1

    CALLER REPORTED THAT THE PT WAS SEEN AT EMERGENCY WITH SHORTNESS OF BREATH. AN XRAY WAS TAKEN AND DETERMINED HIS TRACHEOSTOMY TUBE HAD A FRACTURE AND WAS REMOVED. CUSTOMER REPORTED THAT THE XRAY SHOWED THAT TRACH TUBE HAD FRACTURED AND BOTTOM PART OF TUBE WAS IN RIGHT BRONCHUS. CUSTOMER REPORTED THE PIECE WAS REMOVED WITHOUT FURTHER INCIDENT AND A NEW TRACH INSTALLED. CUSTOMER CONFIRMED PT IS OK AND RETURNED TO NURSING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED TRACH NONE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention