BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC G-18 INTRODUCER KIT

    MDR report key: 3033656 · Received April 3, 2013

    Report

    Report Number
    9611594-2013-00035
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. 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, "THE DILATOR WAS INSERTED AND THE PORTION THAT BROKE OFF DID PASS INTO THE STOMACH BUT ENOUGH WAS RETAINED OUT OF THE STOMACH THAT THE PHYSICIAN WAS ABLE TO RETRIEVE IT WITHOUT FURTHER MEDICAL INTERVENTION." 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
    137068 MIC G-18 INTRODUCER KIT GASTROINTESTINAL ANCHOR SET KNT KIMBERLY-CLARK HEALTH CARE AA2338R03

    Patients

    Seq Age Sex Outcome Treatment
    1