BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC G-14 INTRODUCER KIT

    MDR report key: 2905418 · Received January 9, 2013

    Report

    Report Number
    9611594-2013-00015
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE INVOLVED IN THIS REPORTED EVENT.WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT AS NO LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.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. (B)(4): DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(6), STATING, "HOSPITAL REPORTS REGARDING GASTROPEXY SUTURES BREAKING. A PATIENT HAD ONE SUTURE BREAK AFTER APPROX. ONE WEEK."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
    10410 MIC G-14 INTRODUCER KIT INTRODUCER KIT KNT KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1