BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9617604-2008-00080

    MDR report key: 1062851 · Received June 13, 2008

    Report

    Report Number
    9617604-2008-00080
    Event Type
    Injury
    Date Received
    June 13, 2008
    Product Code
    ---
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INSTRUCTIONS FOR USE REVEALS A WARNING THAT STATES THAT ONLY PARTICULAR SMITHS MEDICAL STYLE ENDOTRACHEAL TUBES (IT LISTS THE CATALOG NUMBERS) ARE INTENDED TO BE USED WITH THIS HOLDER. IT IS LIKELY THAT THE CAUSE OF THIS EVENT WAS DUE TO AN INCORRECT STYLE ENDOTRACHEAL TUBE BEING USED WITH THE HOLDER. THE HOSP HAS BEEN INFORMED OF THE DETAILS CONTAINED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ---

    Patients

    Seq Age Sex Outcome Treatment
    1