BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC

    MDR report key: 2181478 · Received July 25, 2011

    Report

    Report Number
    2181478
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STAFF NOTICED THE GASTROSTOMY FEEDING TUBE COMING OUT OF THE PT AS NUMBERS WERE NOW VISIBLE ON THE TUBING. THE SURGEON CHECKED THE TUBE AND INDICATED IT WAS DISLODGED AND REMOVED THE TUBE. THE BALLOON WAS FELT TO BE DEFLATED IN ERROR DUE TO UNFAMILIARITY WITH THE DEVICE. THE PT WENT TO RADIOLOGY FOR INJECTION OF THE SINUS TRACT FOR THE REINSERTION OF A NEW TUBE THAT WAS UNSUCCESSFUL. THE PT WAS CHANGED TO PARENTERAL NUTRITION UNTIL THEY COULD RETURN TO SURGERY FOUR DAYS LATER FOR A NEW TUBE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC GASTROSTOMY FEEDING TUBE KNT KIMBERLY-CLARK 0100-22 AA1059D05

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O| R