BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER

    MDR report key: 3890941 · Received June 24, 2014

    Report

    Report Number
    1119193-2014-00013
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED ANCHORFAST GUARD DEVICE WAS NOT RETURNED FROM THE USER FACILITY. THE REQUEST FOR PHOTOGRAPHS WAS NOT ACKNOWLEDGED BY THE FACILITY. THE USER FACILITY DID NOT PROVIDE LOT NUMBER OF THE DEVICE OR THE MEDICAL TREATMENT THE PATIENT MAY HAVE RECEIVED FOR THE REPORTED LIP INJURY OR THE NECROSIS ON THE TONGUE. ALL REQUESTS FOR ADDITIONAL INFORMATION WERE DENIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FURTHER INVESTIGATION WILL BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE HOLDER IN PLACE FOR AT LEAST TWO WEEKS AT THE TIME OF THE EVENT. THE PATIENT EXPERIENCED AN UNSTAGEABLE UPPER LIP PRESSURE INJURY UNDER THE INTACT FOAM BUMPER AND THERE WAS ALSO A NECROTIC AREA ON THEIR TONGUE. THE HOSPITAL WOULD NOT PROVIDE FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367265 ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention