BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT ORAL CARE Q2 KIT

    MDR report key: 2960095 · Received February 13, 2013

    Report

    Report Number
    8030647-2013-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 15, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. WITHOUT A LOT NUMBER AND THE RETURNED DEVICE WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT. THE DIRECTIONS FOR USE STATE, "PATIENT'S WITH ALTERED LEVELS OF CONSCIOUSNESS OR WHO CANNOT COMPREHEND COMMANDS MAY REQUIRE USE OF A BITE BLOCK." 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. H3 OTHER TEXT : DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "THE NURSE WAS USING THE SUCTION SWAB WITH ALCOHOL FREE MOUTH WASH ON A PATIENT WHO WAS BITING DOWN A LOT. SHE NOTICED SOMETHING IN THE PATIENTS MOUTH AND IT WAS THE PLASTIC TIP OF THE SUCTION SWAB THAT HAD BROKEN OFF AT THE HOLES. THE TIP WAS REMOVED FROM THE PATIENT'S MOUTH. 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
    63507 KIMVENT ORAL CARE Q2 KIT ORAL CARE KXF KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR