BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLUE LINE TRACHEOSTOMY TUBE

    MDR report key: 755794 · Received August 23, 2006

    Report

    Report Number
    1217052-2006-00052
    Event Type
    Other
    Date Received
    August 23, 2006
    Date of Event
    May 20, 2006
    Report Date
    July 24, 2006
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V., SMITH MEDICAL
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL WAS NOTIFIED THAT THERE WAS AN INJURY SUSTAINED FROM A DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE LINE TRACHEOSTOMY TUBE BREATHING TUBE BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V., SMITH MEDICAL NA 501694

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other