BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC G-14 INTRODUCER KIT

    MDR report key: 2022716 · Received March 17, 2011

    Report

    Report Number
    9611594-2011-00046
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO SIMILAR OBSERVATIONS NOTED BY THE QUALITY AUDITOR. THE SAMPLE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION. 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 STATING, "PROBLEM AT THE REMOVING OF THE DILATOR & THE GUIDE WIRE. ONE PART BROKE OFF, WHICH STAYED IN THE STOMACH." 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 G-14 INTRODUCER KIT PPK INTRODUCER KIT KNT KIMBERLY-CLARK HEALTH CARE AA0200R07

    Patients

    Seq Age Sex Outcome Treatment
    1