BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3872846 · Received June 13, 2014

    Report

    Report Number
    1119193-2014-00012
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 13, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE REPORTED CHEEK SKIN BREAK DOWN CAN NOT BE DETERMINED BUT IS LIKELY RELATED TO THE PATIENTS OVERALL HEALTH STATUS. THE PATIENT'S HEAD TENDED TO WANT TO TURN TOWARDS THE LEFT SIDE. THERE WERE OTHER SITES OF SKIN BREAKDOWN REPORTED ON THE PATIENTS BODY UNRELATED TO THE ANCHORFAST DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ANCHORFAST ORAL ENDOTRACHEAL TUBE HOLDER APPLIED ON (B)(6) 2014. ON (B)(6) 2014 THE ANCHORFAST WAS REMOVED AND SKIN BREAKDOWN WAS NOTED ON THE CHEEK. THE OPEN WOUND WAS ABOUT THE SIZE OF A QUARTER WITH A LARGER DISCOLORED AREA AROUND IT AND IT WAS DETERMINED TO BE STAGE 2/3. THE AREA WAS CLEANED AND COVERED AND KEPT FREE OF PRESSURE. THE PATIENT DIED FROM UNRELATED CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349796 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other