BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMBERLY CLARK

    MDR report key: 1843396 · Received September 22, 2010

    Report

    Report Number
    MW5017526
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    KIMBERLY CLARK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TO BE PERFORMED WAS ESOPHAGOGASTRODUODENOSCOPY (EGD) AND PERCUTANEOUS ENDOSCOPIC GASTROTOMY (PEG). ENDOSCOPE WAS ADVANCED DOWN THROUGH THE MOUTH INTO THE STOMACH. A PEG TUBE PLACEMENT SITE WAS IDENTIFIED. THREE T-FASTENERS WERE PASSED AND SECURED INTO POSITION. UTILIZING THE RUSSELL KIT, A GUIDEWIRE WAS PASSED WHICH WAS GRABBED WITH THE ENDOSCOPIC SNARE. THE PROGRESSIVE ENLARGING DILATING CATHETERS AND THE INTRODUCER WAS PASSED. THE FIRST DILATOR WAS REMOVED. THE SECOND DILATOR WOULD NOT COME OUT AND SNAPPED. UNABLE TO REMOVE DILATORS FROM TRACT. AN ATTEMPT WAS DONE TO REMOVE THESE INTERNALLY WHICH WAS UNSUCCESSFUL. DECISION TO PLACE A WIRE THROUGH THIS AND PULL THIS OUT THROUGH THE MOUTH. A STANDARD 20-FRENCH MIC FEEDING TUBE WAS PLACED, REMOVING ALL THE RUSSEL KIT OUT THROUGH THE ABDOMINAL WALL DURING THE PULL-THROUGH PROCEDURE. PT WAS RE-ENDOSCOPED AND THE PEG TUBE WAS IN GOOD POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK MIC' G 20-INTRODUCER KIT KNT KIMBERLY CLARK REF # 98724 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention