BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY G-20 INTRODUCER KIT

    MDR report key: 2251805 · Received September 16, 2011

    Report

    Report Number
    9611594-2011-00110
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THE PRODUCT MET SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 FROM (B)(6) STATING, "DURING PERCUTANEOUS PLACEMENT OF GASTROSTOMY ALL BUT 1 DILATOR FELL INTO THE PATIENTS STOMACH, WHEN THE DOCTOR WENT TO RETRIEVE THE DILATORS HE BROKE ALL 4 SUTURES THAT HE HAD PLACED. THE PATIENT REQUIRED AN OPEN PROCEDURE TO COMPLETE THE GASTROSTOMY. PATIENT IS DOING OK." 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 MIC-KEY G-20 INTRODUCER KIT PPK INTRODUCER KIT KNT KIMBERLY-CLARK HEALTH CARE AA0172R12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention