BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 6012289 · Received October 7, 2016

    Report

    Report Number
    1119193-2016-00023
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    July 13, 2016
    Report Date
    October 7, 2016
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL SKIN TEAR WAS NOTED ON THE PATIENTS FRONT RIGHT CHEEK WHEN THE ANCHORFAST ENDOTRACHEAL TUBE HOLDER WAS REMOVED. IT IS NOT KNOWN WHEN THE ANCHORFAST ENDOTRACHEAL TUBE HOLDER WAS APPLIED AS THE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL. OVER THE FOLLOWING WEEKS, THE SMALL TEAR PROGRESSED INTO A LARGE AND INVASIVE FUNGAL INFECTION. THE WOUND REQUIRED DEBRIDEMENT ON TWO OCCASIONS BY THE PLASTICS TEAM. THE PATIENT WAS NOTED TO BE EXTREMELY IMMUNOCOMPROMISED PLACING HER AT HIGH RISK FOR FUNGAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662335 ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other