BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMBERLY-CLARK

    MDR report key: 4810414 · Received May 28, 2015

    Report

    Report Number
    MW5042872
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 21, 2015
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN OUR ENDOSCOPY SUITE FOR A REPLACEMENT OF HIS MIC-KEY ENTERAL FEEDING TUBE. WHILE THE DILATOR WAS BEING USED THROUGH A CONSTRICTED AREA IT CAME APART LEAVING THE RIDGED SERIAL DILATOR IN THE PATIENT'S STOMACH. THIS WAS NOT ABLE TO BE RETRIEVED IN THE ENDOSCOPY SUITE. THE PATIENT WENT TO THE OPERATING ROOM FOR REMOVAL AND PLACEMENT OF THE FEEDING TUBE. WE HAVE RETAINED THE PIECE REMOVED FROM THE PATIENT. THE REPORT WAS DELAYED DUE GETTING IN TOUCH WITH THE REP FROM THE COMPANY TO GET INFORMATION FROM THEM ABOUT THE PRODUCT SINCE IT WAS SOMETHING BROUGHT IN BY THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346766 KIMBERLY-CLARK ENTERAL ACCESS DILATION SYSTEM KNT KIMBERLY-CLARK 98706

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R