BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9617604-2008-00081

    MDR report key: 1062966 · Received June 13, 2008

    Report

    Report Number
    9617604-2008-00081
    Event Type
    Injury
    Date Received
    June 13, 2008
    Product Code
    CBH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATIONS CODES (OTHER): A REVIEW OF THE INSTRUCTIONS FOR USE REVEALS A WARNING THAT STATES THAT ONLY PARTICULAR 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 HOSPITAL HAS BEEN INFORMED OF THE DETAILS CONTAINED IN THE INSTRUCTIONS FOR USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1