BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROINTESTINAL ANCHOR SET WITH HEMOSTAT

    MDR report key: 2080494 · Received May 6, 2011

    Report

    Report Number
    9611594-2011-00061
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 8, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. THE SAMPLE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION. THE T-PIECE ASSEMBLY IS MANUFACTURED USING ABSORBABLE SUTURE AND IS DESIGNED SO THE T-PIECE SEPARATES FROM THE SUTURE AFTER A FEW WEEKS. THE T-PIECE IS DESIGN TO BE RELEASED INTO AND TO PASS THROUGH THE GI TRACT. 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. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "T-FASTNER BROKE AWAY FROM SUTURE INTO PATIENT. PATIENT WAS TAKEN TO PEDIATRIC GI AND A PEG WAS PLACED, AND THE T-BARS WERE REMOVED WITH AN ENDOSCOPE." 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. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention