BEUDAMED
    FDA Adverse Event Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3020040 · Received March 25, 2013

    Report

    Report Number
    1119193-2013-00002
    Date Received
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NUMEROUS ATTEMPTS HAVE BEEN MADE BY HOLLISTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT OF A LIP PRESSURE ULCER AND A FOAM BUMPER SEPARATION. THE HOSPITAL HAS NOT RESPONDED TO THE REQUESTS FOR INFORMATION. WITHOUT THE SAMPLE OR LOT NUMBER WE ARE UNABLE TO EVALUATE THE REPORTED FOAM BUMPER SEPARATION FROM THE DEVICE. WE ARE CONTINUING TO MONITOR THE PERFORMANCE OF THE ANCHORFAST DEVICE IN OUR POST MARKETING SURVEILLANCE SYSTEM AND WILL TAKE ANY CORRECTIVE OR PREVENTIVE ACTION THAT APPEARS WARRANTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: CLINICIANS NOTED AN UPPER LIP PRESSURE ULCER ON A PATIENT. UPON REMOVAL OF THE DEVICE, IT APPEARED THAT THE FOAM BUMPER OF THE ANCHORFAST ENDOTRACHEAL TUBE FASTENER HAD SEPARATED AND WAS UNABLE TO BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121875 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1