BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCT SPECIALIZED TRACH

    MDR report key: 2297993 · Received October 11, 2011

    Report

    Report Number
    2936999-2011-00630
    Event Type
    Injury
    Date Received
    October 11, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 15, 2011
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HE
    Product Code
    JOH
    PMA / PMN Number
    K903435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THEY REC'D AN M8SCT TRACHEOSTOMY TUBE WITH THE WRONG CURVE. THE PT WAS RECANNULATED WITH AN OLDER TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCT SPECIALIZED TRACH TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HE 1010000790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention