BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW-PROFILE GASTROSTOMY TUBE

    MDR report key: 1232713 · Received November 14, 2008

    Report

    Report Number
    9611594-2008-00017
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 12, 2008
    Report Date
    November 13, 2008
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT SAMPLE HAS NOT YET BEEN RECEIVED FOR EVALUATION. INVESTIGATION IS IN-PROCESS. THE PATIENT'S STOMA SITE WAS REPORTED TO BE IMPROVING. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL 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 HAS BEEN REPORTED BY A CUSTOMER THAT FOR 3 DAYS, HER DAUGHTER SUFFERED PAIN AND BLEEDING AT THE STOMA SITE. THE CUSTOMER REMOVED THE BUTTON AND PLACED A FOLEY CATHETER UNTIL THE DOCTOR COULD BE SEEN. IN THE EMERGENCY ROOM, THE STOMA WAS FOUND TO BE COMPLETELY TORN AROUND THE INTERIOR CIRCUMFERENCE. ULTRASOUND REVEALED NO INTERNAL DAMAGE. WHILE CLEANING MIC-KEY LOW-PROFILE GASTROSTOMY TUBE FOR REINSERTION, THE CUSTOMER ALLEGEDLY FOUND A SMALL PIECE OF PLASTIC ON THE NECK OF THE BALLOON. THE CUSTOMER REPORTED THAT THE PIECE WAS SLICING AROUND THE STOMA WITH FREQUENT BUTTON TURNING. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH. 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-KEY LOW-PROFILE GASTROSTOMY TUBE GASTROSTOMY TUBE KNT AVENT SA DE R.L. DE C.V. 404023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention