BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE ADULT ECG ELECTRODE

    MDR report key: 2963812 · Received February 15, 2013

    Report

    Report Number
    1320894-2013-00014
    Date Received
    February 15, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 15, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLEARTRACE ECG ELECTRODE IS AN ELECTROCARDIOGRAPH ELECTRODE, AN ELECTRICAL CONDUCTOR WHICH IS APPLIED TO THE SURFACE OF THE BODY INTENDED TO TRANSMIT THE ELECTRICAL SIGNAL AT THE BODY SURFACE TO A PROCESSOR VIA LEAD WIRES AND CABLES THAT PRODUCE AN ELECTROCARDIOGRAM TO BE USED BY THE CLINICIAN IN DIAGNOSING OR MONITORING A PATIENT'S CONDITION. THIS PRODUCT IS A SINGLE USE, DISPOSABLE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, FOR LOT NUMBER 1212071 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. FOUR (4) CLEARTRACE ECG ELECTRODES WERE RETURNED TO CONMED COMPLAINT HANDLING CENTER FOR EVALUATION. THESE ELECTRODES WERE RECEIVED IN AN OPEN POUCH. THE RETURNED DEVICES WERE EXAMINED IN THE LABORATORY. NO CONTAMINANTS OR OTHER DEFORMITIES WERE OBSERVED WITH THE RETURNED DEVICES. THE GEL WAS SLIGHTLY DRIED OUT DUE TO THE STORAGE CONDITION (OPEN POUCH). HOWEVER, CUSTOMER COMPLAINT FAILURE MODE WAS CONFIRMED DUE TO THE PHOTOGRAPH OF THE SKIN REACTION PROVIDED TO CONMED BY THE END-USER. BASED ON THE PHOTOGRAPH, EVENT DESCRIPTION PROVIDED BY THE END-USER, AND VISUAL EXAMINATION OF THE DEVICES, IT IS HIGHLY LIKELY THIS EVENT IS AN ALLERGIC REACTION TO THE ADHESIVE COMPONENT OF THE ECG ELECTRODES.. PER THE PATIENT COMPLETED ECG SURVEY THE END-USER WAS NEVER ADVISED OF A SPECIFIC SITE PREPARATION AND USED JUST SOAP AND WATER PRIOR TO APPLICATION OF THE ECG ELECTRODES. THE END-USER ALSO STATED THAT SHE CHANGED THE ECG ELECTRODES EVERY THREE (3) DAYS AS INSTRUCTED. IT IS POSSIBLE THAT THE PATIENT HAD SOLVENTS UNDER THE ELECTRODE SITE SUCH AS THAT SKIN SOAP WHICH COULD HAVE CAUSED THE IRRITATION. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES THAT, "THE ELECTRODE SITE SHOULD BE DRY BEFORE ELECTRODE APPLICATION. FLUIDS, INCLUDING SKIN CLEANSING SOLUTIONS, LOTIONS OR SOAPY WATER MAY CAUSE SKIN IRRITATION AND LOSS OF ADHESION." THE MOST LIKELY POSSIBLE CAUSE OF THE COMPLAINT IS A PATIENT ALLERGIC REACTION TO THE ADHESIVE COMPONENT OF THE DEVICE. THESE CLEARTRACE ECG ELECTRODES ARE TESTED AND PASSED FOR BIOCOMPATIBILITY. THE CLEARTRACE ECG ELECTRODES GEL, AS WELL AS THE BASE PAD MATERIALS, ARE TESTED FOR CYTOTOXICITY, SENSITIZATION, AND INTRACUTANEOUS FACTOR PER (B)(4) APPROVED TESTING. IN PROCESS INSPECTION AND VISUAL CHECKS WERE DONE TO ENSURE PROPER PRODUCTION OF THE DEVICES. THE INVOLVED DEVICES DID NOT FAIL TO MEET SPECIFICATIONS DURING THE DIAGNOSTIC UTILIZATION OF HOLTER MONITORING. THE UNANTICIPATED, SHORT-TERM SKIN REACTION IS A DIRECT RESULT OF AN ALLERGIC PATIENT REACTION TO AN ADHESIVE COMPONENT OF THE DEVICE. NO CONCLUSIVE MANUFACTURING RELATED DEFECTS WERE OBSERVED WITH THE GEL OR THE ELECTRODE BASE PAD; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "USED AN EVENT HOLTER MONITOR AND USED THE CLEARTRACE ADULT ECG ELECTRODES. I BELIEVE THE PRODUCT NUMBER IS (B)(4). I DEVELOPED AN ALLERGIC SENSITIVITY TO SOMETHING IN THE ELECTRODE. ONLY FOR THE PURPOSE OF PREVENTING A FUTURE PROBLEM, I WONDER IF YOU KNOW WHAT INGREDIENTS ARE USED IN THE ADHESIVE PORTION OF THE ELECTRODE. I AM ATTACHING A PICTURE OF MY REACTION TO THEIR USE, AS IT MAY HAVE OCCURRED WITH OTHER PEOPLE. AGAIN, MY ONLY INTENTION WITH MY INQUIRY IS TO AVOID THE INGREDIENT (IF POSSIBLE) IN THE FUTURE". THE CARDIAC MONITORING PERIOD WAS FROM (B)(6) 2012 THROUGH (B)(6) 2013. THE PATIENT REPORTED THAT SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND PRESCRIBED TRIAMCINOLONE OINTMENT FOR TREATMENT OF THE SKIN IRRITATION. PHOTOGRAPH OF THE SKIN REACTION WAS SENT TO CONMED BY THE PATIENT. THE REACTION WAS IN THE SHAPE OF A RING (THE SHAPE OF THE ADHESIVE PORTION OF THE ECG ELECTRODE). THE PATIENT WAS PROVIDED WITH A COPY OF CONMED'S TECHNICAL DATA SHEET FOR THE DEVICE IDENTIFYING ALL INGREDIENTS OF THE DEVICE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68298 CLEARTRACE ADULT ECG ELECTRODE CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION 1212071

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other