BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 1862014 · Received October 8, 2010

    Report

    Report Number
    9611594-2010-00049
    Event Type
    Injury
    Date Received
    October 8, 2010
    Report Date
    September 13, 2010
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR THE POSSIBLE LOT NUMBERS PROVIDED BY THE CUSTOMER (AA9348D08; AA9341D08; AA0088D13; AA0060D06)WITH NO SIMILAR OBSERVATIONS NOTED BY THE QUALITY SYSTEMS AUDITOR. NO SAMPLE WAS RETURNED BY THE CUSTOMER 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 WAS NOT RETURNED BY THE CUSTOMER TO KIMBERLY-CLARK FOR EVALUATION.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM DISTRIBUTOR IN (B)(4), STATING, " THE PATIENT ARRIVES TO THE HOSPITAL ON AUGUST 22ND WITH SECONDARY SEPSIS IN STOMA ACCESS. THE PATIENT GOES HOME ON SEPTEMBER 7TH. QUESTIONED IF SOME MANIPULATION OCCURRED. THEY ASSURE THAT THE PATIENT FOLLOWED ALL THE RECOMMENDATIONS." POSSIBLE LOT NUMBERS INCLUDE AA9348D08; AA9341D08; AA0088D13; AA0060D06. 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC GASTROSTOMY FEEDING TUBE G TUBE KNT KIMBERLY-CLARK HEALTH CARE AA9348D08+

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization