BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 1022220 · Received March 26, 2008

    Report

    Report Number
    9611594-2008-00003
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    October 16, 2007
    Report Date
    March 27, 2008
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    KNT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, A FOLLOW-UP REPORT WILL BE PROVIDED WHEN ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY KC SALES REP THAT THE BUTTON BECAME POROUS DURING USE AND PARTS OF THE BUTTON GOT INTO STOMACH OF THE PATIENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE GASTROINTESTINAL TUBE AND ACCESSORIES KNT AVENT SA DE R.L. DE C.V. NA

    Patients

    Seq Age Sex Outcome Treatment
    1