BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT DENTASWAB ORAL CARE SWAB

    MDR report key: 2493654 · Received March 15, 2012

    Report

    Report Number
    8030647-2012-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LOT NUMBER REPORTED, THE DEVICE HISTORY RECORD WAS REVIEWED, AND IT DOCUMENTED THAT THE PRODUCT MET MANUFACTURING SPECIFICATIONS. AN UNUSED SWAB SPONGE IN A SEALED CELLOPHANE PACK WAS RECEIVED ALONG WITH A SWAB STICK THAT WAS LOOSE AND NOT WITHIN THE CELLOPHANE PACK. NO DESCRIPTION OF THE RETURNED OBJECTS WAS PROVIDED, AND CURRENTLY IT IS NOT KNOWN HOW THE RETURNED SWAB AND STICK ARE ASSOCIATED IN THE INCIDENT SINCE NO ADDITIONAL DOCUMENTATION WAS PROVIDE WITH THE RETURNED SAMPLE. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED. 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. SIMILAR UNUSED DEVICE RETURNED.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6), STATING, "WHILE MOM WAS BRUSHING HER TEETH AND SWABBING HER MOUTH, THE SPONGE CAME OUT IN HER DAUGHTER'S MOUTH. THERE WAS NO INJURY OR MEDICAL INTERVENTION REQUIRED BUT WANTED TO ALERT US OF THE ISSUE." 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
    1 KIMVENT DENTASWAB ORAL CARE SWAB ORAL CARE SWAB KXF KIMBERLY-CLARK HEALTH CARE M0293A201

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR