BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINERGY COOLED RADIOFREQUENCY KIT

    MDR report key: 2974899 · Received February 22, 2013

    Report

    Report Number
    8030647-2013-00006
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NUMBER M2311D201, AND THE LOT WAS DOCUMENTED TO HAVE MET REQUIREMENTS. BASED ON THE LOT NUMBER REFERENCED IN THE REPORT, THE PRODUCT WAS A SINERGY COOLED RADIOFREQUENCY KIT. BASED ON THE PICTURES PROVIDED BY THE CUSTOMER, THE PACKAGING SLEEVE/LABEL SHOWED THE GRAPHICS FOR A CERVICOOL COOLED RADIOFREQUENCY KIT, WHICH MAY HAVE BEEN PLACED ON A BOX CONTAINING THE SINERGY COOLED RADIOFREQUENCY KIT; HOWEVER, THIS INVESTIGATION IS ON-GOING AND A HEALTH EVALUATION IS BEING INITIATED. 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. DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "WE DISCOVERED THIS MISLABELING ON AN ORDER THAT WAS SENT TO (B)(6). I HAD HIM SEND ME PICTURES OF THE KITS IN QUESTION. ONE HAS THE SINERGY LABELS ON THE CERVICOOL KIT, SO THEY PICKED IT AND SHIPPED IT LIKE A SINERGY KIT." NO PATIENT INJURY REPORTED. 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
    79059 SINERGY COOLED RADIOFREQUENCY KIT GXI KIMBERLY-CLARK HEALTH CARE M2311D201

    Patients

    Seq Age Sex Outcome Treatment
    1