BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTRACE; 1; FM, WTGEL

    MDR report key: 6658562 · Received June 21, 2017

    Report

    Report Number
    1320894-2017-00135
    Event Type
    Injury
    Date Received
    June 21, 2017
    Date of Event
    September 24, 2016
    Report Date
    June 21, 2017
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K963787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNABLE TO BE CONFIRMED DUE TO THE DEVICE BEING DISCARDED BY THE HOSPITAL. THESE ELECTRODES CONTAIN LECTRON III 4% GEL COMPONENT AND A PE FOAM COMPONENT WHICH HAS BEEN TESTED FOR CYTOTOXICITY, SENSITIZATION AND INTRACUTANEOUS. A REVIEW OF DEVICE HISTORY REVEALED 4 COMPLAINTS HAVE BEEN REPORTED IN THE PAST TWO YEARS. DURING THIS SAME TWO-YEAR TIME FRAME, (B)(4) DEVICES HAVE BEEN SOLD WORLDWIDE MAKING THE CALCULATED OCCURRENCE PROBABILITY (B)(4). A RISK ANALYSIS WAS PERFORMED AND DETERMINED THE RISK TO BE ACCEPTABLE. THE IFU STATES THE FOLLOWING TO MITIGATE THIS POTENTIAL ISSUE: "SELECT AND PREPARE ELECTRODE SITES ACCORDING TO YOUR HEALTH CARE FACILITY'S PROTOCOL FOR ECG MONITORING. THE ELECTRODE SITES SHOULD BE CLEAN, DRY, AND FREE FROM SKIN OIL PRIOR TO ELECTRODE APPLICATION. CHECK THE EXPIRATION DATE ON THE UN-OPENED POUCH OF ELECTRODES. ELECTRODES MUST BE USED BEFORE EXPIRATION DATE INDICATED ON THE PACKAGE. TO MINIMIZE SKIN TRAUMA DURING ELECTRODE REMOVAL, LIFT SLOWLY AND GENTLY FROM THE PEEL TAB OR ELECTRODE EDGE." TO DATE, THERE HAVE BEEN NO PATIENT LONG TERM EFFECTS RESULTING FROM THIS REPORTED PROBLEM. THE REPORTED PROBLEM WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ENSURE PATIENT/PRODUCT SAFETY. DEVICE WAS DISCARDED BY USER FACILITY.

    Description of Event or Problem · 1

    CONMED CORPORATION RECEIVED A PRODUCT EXPERIENCE REPORT CONTAINING ADVERSE EVENT INFORMATION FROM THE (B)(6). SYMMETRICAL TO THE EXACTRACE ELECTRODE PLACEMENT, THERE WAS A LARGE RED BUBBLING AREA ON THE SKIN OF THE THIGH. THIS WAS PRIMARILY INTERPRETED AS AN ALLERGIC REACTION. THIS DEVELOPED OVER TIME AND THE WOUND STARTED TO DEVELOP AN INFECTION. THE WOUND BECAME DEEP AND THE PATIENT HAS PROBLEMS IN THE FORM OF PAIN, ETC. AND STILL HAS TODAY. AT THIS TIME, WE HAVE BEEN UNABLE OBTAIN ADDITIONAL PATIENT/EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437323 EXACTRACE; 1; FM, WTGEL ELECTROCARDIOGRAPH ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1