BEUDAMED
    FDA Adverse Event Summary report: N

    KIMVENT ORAL CARE SWABS

    MDR report key: 3193517 · Received June 27, 2013

    Report

    Report Number
    8030647-2013-00015
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. FIVE SAMPLES WERE RETURNED BUT WERE NOT IN A VIABLE CONDITION 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.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM GERMANY STATING, ¿THE SWAB'S BREAK DURING USE.¿ 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
    294385 KIMVENT ORAL CARE SWABS KXF KIMBERLY-CLARK HEALTH CARE M2352A202

    Patients

    Seq Age Sex Outcome Treatment
    1