BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMVENT ORAL SUCTION KIT

    MDR report key: 1591627 · Received January 29, 2010

    Report

    Report Number
    8030647-2010-00001
    Event Type
    Other
    Date Received
    January 29, 2010
    Report Date
    December 31, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS BEEN RECEIVED BUT NOT YET EVALUATED. INVESTIGATION IN-PROCESS. NO ADDITIONAL INFORMATION RECEIVED AT THIS TIME. 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 COMPLAINT INDICATING THAT WHILE USING ONE OF THE SUCTION PROBES PROVIDED IN THE KIT, "...THE BLUE TIP CAME OFF IN THE PATIENT'S MOUTH AND WENT DOWN HIS THROAT, THEY RETRIEVED IT WITHOUT ANY INJURY TO THE PATIENT." NO PATIENT INJURY. 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 PIR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMVENT ORAL SUCTION KIT ORAL CARE JOL AVENT S. DE R.L. DE C.V. M9124A704

    Patients

    Seq Age Sex Outcome Treatment
    1