BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC G-14 INTRODUCER KIT

    MDR report key: 2931187 · Received January 28, 2013

    Report

    Report Number
    9611594-2013-00004
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 27, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW , THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6), STATING, "PERCUTANEOUS GASTROSTOMY PERFORMED BY THE RADIOLOGICAL THE (B)(6) EARLY AFTERNOON, WITH 3 POINTS OF GASTROPEXY WITHOUT PROBLEM DURING THE PROCEDURE, OR IMMEDIATELY AFTER .THE PATIENT STAYED IN BED UNTIL THE (B)(6) IN THE MORNING. THE NURSES FOUND THE THREE ANCHOR SETS FALLEN WITH SUTURE BAND CUT WHEN RE-DRESSING." NO PATIENT INJURY. GASTROPEXY WAS MAINTAINED WITH BALLOON FEEDING TUBE. 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
    36816 MIC G-14 INTRODUCER KIT INTRODUCER KIT KNT KIMBERLY-CLARK HEALTH CARE AA2122R02

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR