BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST ORAL ENDOTRACHEAL DEVICE

    MDR report key: 2423974 · Received January 20, 2012

    Report

    Report Number
    1119193-2012-00001
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    January 20, 2012
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EXPLANATION OF THE INCIDENT, IT IS POSSIBLE THAT EXCESSIVE FORCE BEYOND REASONABLY EXPECTED FORCE WAS APPLIED TO THE TUBE/CLAMP DURING THE PATIENT REPOSITIONING WHICH CAUSED THE CLAMP TO BREAK AWAY FROM THE TRACK. IT CAN NOT BE VERIFIED WITHOUT THE RETURN OF THE SAMPLE. THIS REPORT OR INFORMATION SUBMITTED DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, HOLLISTER INCORPORATED OR HOLLISTER EMPLOYEE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WHO WAS 4 DAYS POST CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, WAS BEING ROLLED THE ANCHORFAST TUBE CLAMP SEPARATED FROM THE TRACK WITHOUT BREAKING. IT IS UNKNOWN IF THERE WAS ANY TORQUE OR TRACTION APPLIED TO THE SYSTEM WHEN THIS SEPARATION OCCURRED. THE PATIENT WAS COUGHING AT THIS TIME AND BECAME EXTUBATED. REINTUBATION WAS REQUIRED. THE DEVICE HAD BEEN IN PLACE FOR 4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORFAST ORAL ENDOTRACHEAL DEVICE ANCHORFAST ETAD CBH HOLLISTER INCORPORATED 9799 1K182

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O