BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILTUBE

    MDR report key: 2920199 · Received November 30, 2012

    Report

    Report Number
    2938401-2012-00003
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC./INTEGRA BIOTECHNICAL, LLC
    Product Code
    CBH
    PMA / PMN Number
    K935171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION SUBMITTED BY THE USER ON THE MEDWATCH FORM AND SUBSEQUENT INTERVIEWS WITH THE USER, B&B ASSUMES THE INFORMATION PROVIDED WAS ACCURATE AND COMPLETE. THE DEVIATIONS TO THE IFU ARE LISTED BELOW: THE FACE WAS APPARENTLY NOT CLEANED. THE SKIN PREP WAS APPARENTLY NOT APPLIED. THIS FAILURE TO PREPARE THE APPLICATION SITE IS LIKELY TO HAVE CAUSED TISSUE DAMAGE, WHICH MAY OR MAY NOT HAVE BEEN CAUSED BY UNKNOWN TOXINS, BACTERIAL, FUNGAL, OR OTHERS AGENTS. FAILURE TO DETERMINE THE APPROPRIATE INTERVAL OF ROUTINE CHECKING DURING THE 6 DAYS THE DEVICE WAS USED, MOREOVER, APPARENTLY, ACCEPTED INDUSTRY STANDARDS IN APPLICATION OF THE DEVICE WERE NOT USED TO DETERMINE THIS INTERVAL BASED ON THE PT'S CONDITION. (THE NATIONAL PRESSURE ULCER ADVISORY PANEL, WWW.NPUAP.ORG). FAILURE TO REPLACE APPROPRIATELY. FURTHER ANALYSIS IS NOT POSSIBLE BECAUSE: NO INFORMATION WAS SUPPLIED ON THE PT CONDITION. NO ANALYSIS WAS APPARENTLY DONE OF THE NECROTIC TISSUE TO DETERMINE IF THE NATURE OF ANY POSSIBLE CONTAMINATION WAS ORGANIC OR NOT, OR WHETHER THIS WAS FROM THE PT OR AN EXTERNAL SOURCE. THE DEVICE WAS NOT RETURNED. NO PICTURES OF THE TISSUE DAMAGE WERE AVAILABLE. STATISTICAL ANALYSIS: (B)(4). CONCLUSION: WE BELIEVE THIS INCIDENT WAS CAUSED BY MULTIPLE USER ERRORS AND IS SUPPORTED BY SOUND STATISTICAL ANALYSIS.

    Description of Event or Problem · 1

    THE STABILTUBE WAS APPLIED TO THE PT'S UPPER LIP AREA. THE SKIN UNDERNEATH HAD NOT BEEN ROUTINELY CHECKED. THIS RESULTED IN A MUCOUS MEMBRANE ULCER THAT WAS UNSTAGEABLE AND NECROTIC. A PLASTIC SURGERY CONSULT WAS DONE DUE TO OPEN AREA ON THE PT'S UPPER LIP. THE SURGEON FOUND THAT THERE IS DENSE ESCHAR EXTENDING TRANSVERSELY ACROSS THE UPPER LIP JUST ABOVE THE VERMILION PRIMARILY ON THE LEFT SIDE, BUT EXTENDS ACROSS THE MIDLINE. IT IS 1 CM AT IT'S WIDEST POINT AND 4 CM IN LENGTH. ON THE MUCOSAL SIDE, THERE IS A SIMILAR BUT MUCH SMALLER AREA OF NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILTUBE ENDOTRACHEAL TUBE HOLDER CBH B & B MEDICAL TECHNOLOGIES, INC./INTEGRA BIOTECHNICAL, LLC D215801

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention