BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERC TRACH TUBE

    MDR report key: 753738 · Received August 23, 2006

    Report

    Report Number
    1217052-2006-00063
    Event Type
    Injury
    Date Received
    August 23, 2006
    Date of Event
    July 19, 2006
    Report Date
    August 1, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INJURY WOULD HAVE BEEN PRIOR TO THE USE OF SMITHS MEDICAL ASD, INC. PRODUCT. OUR TUBE IS PLACED AFTER THE COOK BLUE RHINO PDT KIT IS USED. THE REPORTED INJURY WOULD HAVE OCCURRED DURING THE PROCEDURE WITH THE COOK PRODUCT. CONCLUSION: THE INJURY DESCRIBED IN THIS REPORT WOULD HAVE BEEN WITH THE COOK BLUE RHINO PDT KIT, WHICH WAS USED PRIOR TO OUR PERC TRACH TUBE BEING PLACED.

    Description of Event or Problem · 1

    USER ALLEGES THAT THEY HAVE HAD AN EVENT OF POSTERIOR TRACHEAL PERFORATION. TRACHEAL DILATION IS BEING DONE USING A COOK BLUE RHINO PDT KIT AS THEY ARE NOT PERFORMING A MULTI DILATOR PROCEDURE PDT PROCEDURE. THEY PUT IN OUR PER-FIT TUBE AFTER THE DILATION IS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC TRACH TUBE TRACHEOSTOMY TUBE BTO SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention COOK BLUE RHINO PDT KIT