BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROINTESTINAL ANCHOR SET WITH HEMOSTAT

    MDR report key: 2241912 · Received September 9, 2011

    Report

    Report Number
    9611594-2011-00112
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED. DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. THE DIRECTIONS FOR USE STATES, "THE KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY T-FASTENERS IS INTENDED TO AFFIX THE STOMACH TO THE ANTERIOR ABDOMINAL WALL FACILITATING PRIMARY PLACEMENT OF THE KIMBERLY-CLARK MIC AND MIC-KEY BRAND ENTERAL FEEDING TUBES." INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "T-FASTENERS FALL OFF AFTER (B)(6). SAF-T-PEXY SET IS USED, BY CARDIOTHORACIC SURGEON DURING ESOPHAGECTOMY, TO PLACE A DIRECT JEJUNOSTOMY. ONCE THE JEJUNUM IS SECURED TO THE ABDOMINAL WALL A FOLEY CATHETER IS PLACED IN THE OPENING OF THE ABDOMINAL WALL TO THE BOWEL. THE FOLEY IS SUTURED TO THE ABDOMINAL WALL, THE BALLOON IS NOT INFLATED IN ORDER TO AVOID BLOCKING THE JEJUNUM. WHEN THE SUTURES FAILED THE PATIENT REQUIRED AN OPEN PROCEDURE IN ORDER TO SECURE THE JEJUNOSTOMY." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GASTROINTESTINAL ANCHOR SET WITH HEMOSTAT SAF-T-PEXY SET KNT KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1