BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE ADULT ECG ELECTRODE

    MDR report key: 2930270 · Received January 25, 2013

    Report

    Report Number
    1320894-2013-00009
    Date Received
    January 25, 2013
    Date of Event
    November 14, 2012
    Report Date
    January 25, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. THE CLEARTRACE ECG ELECTRODES WERE DISCARDED BY THE END-USER. THE ORIGINAL DEVICES OR PICTURES OF THE DEVICES OR SKIN REACTION WERE NOT AVAILABLE; THEREFORE, AN INVESTIGATION ON THE SUSPECT DEVICE CANNOT BE ACCOMPLISHED. NO PRODUCT WAS RETURNED FOR EVALUATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT. DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW COULD NOT BE ACCOMPLISHED AS THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. THE PATIENT SURVEY OFFERED INFORMATION REGARDING DEVICE USAGE SUCH AS SKIN SITE PREPARATION, (SURVEY STATES PATIENT CLEANED THE AREA WITH SOAP, AND, NO SKIN PREPARATION WAS DONE), SITE ROTATION FREQUENCY (SURVEY STATES ELECTRODES WERE CHANGED EVERY ONE TO TWO DAYS), HOW DEVICES WERE REMOVED FROM THE SKIN SURFACE (SURVEY STATES THE ELECTRODES FELL OFF). THERE COULD BE MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED ISSUES FOR THIS FAILURE MODE. LACK OF OR IMPROPER SKIN PREPARATION COULD RESULT IN SOLVENTS UNDER THE ELECTRODE SITE SUCH AS SKIN LOTIONS OR SKIN SOAP WHICH COULD HAVE CAUSED THE SKIN IRRITATION. THE PATIENT SURVEY STATED THAT THE ELECTRODE SITES WERE CLEANED WITH SOAP, OR, NO PREPARATION TO THE SITE. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES, "THE ELECTRODE SITES SHOULD BE CLEAN, DRY, AND FREE FROM SKIN OIL PRIOR TO ELECTRODE APPLICATION". THE IFU, ALSO STATES THAT, "THE ELECTRODE SITE SHOULD BE DRY BEFORE ELECTRODE APPLICATION. FLUIDS INCLUDING SKIN CLEANING SOLUTIONS, LOTIONS OR SOAPY WATER MAY CAUSE SKIN IRRITATION AND LOSS OF ADHESION". THESE ELECTRODES ARE TESTED AND PASSED FOR BIOCOMPATIBILITY. ALL ECG ELECTRODES MATERIALS ARE TESTED FOR CYTOTOXICITY, SENSITIZATION, AND INTRACUTANEOUS FACTOR PER ISO APPROVED TESTING. IN PROCESS INSPECTION AND VISUAL CHECKS WERE DONE TO ENSURE PROPER PRODUCTION OF THE DEVICES. THE PATIENT MAY HAVE EXPERIENCED AN ALLERGIC RESPONSE TO A COMPONENT OF THE DEVICE SUCH AS ELECTRODE ADHESIVE AND / OR GEL. LIKELY CAUSES OF THIS FAILURE MODE INCLUDE TRAPPED SOLVENTS UNDER THE ECG ELECTRODE DEVICE, OR, ALLERGIC RESPONSE TO AN ELECTRODE COMPONENT. THE COMPLAINT CANNOT BE CONFIRMED OR UNCONFIRMED AT THIS TIME DUE TO THE LACK OF ACTUAL DEVICES UTILIZED IN THE REPORTED INCIDENT. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED OR CONFIRMED ANY MANUFACTURING DEFECTS ASSOCIATED WITH THE COMPLAINT; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. FUTURE COMPLAINTS WILL BE TRACKED THROUGH CONMED COMPLAINT METHODOLOGY. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE NOT RETURNED TO CONMED CORP.

    Description of Event or Problem · 1

    IT WAS REPORTED," PATIENT COMPLAINT THAT INVOLVED CONMED ELECTRODES USED IN CONJUNCTION WITH THE ACT III SENSOR. THE CARDIAC MONITORING ENROLLMENT PERIOD WAS SCHEDULED FOR (B)(6) 2012. THE PATIENT CALLED (B)(6)., TO REPORT A SKIN IRRITATION FROM THE ELECTRODES ON (B)(6) 2012. THE PATIENT REPORTED REDNESS, ITCHING, RASH, SMALL BLISTERS, FLUID DISCHARGE, (B)(6) INFECTION AND YEAST INFECTION." CLEARTRACE ECG ELECTRODES (CATALOG NUMBER UNKNOWN {1700-???}, LOT NUMBER UNKNOWN) WERE POTENTIALLY UTILIZED. THE PATIENT REPORTED AN OFFICE CONSULT WITH A MEDICAL PROFESSIONAL FOR TREATMENT OF THE SKIN IRRITATION. ANTIBIOTICS WERE PRESCRIBED BY THE PHYSICIAN; HOWEVER, THE NAME OF THE PRESCRIBED MEDICATION IS UNKNOWN. PHOTOGRAPHS WERE NOT AVAILABLE OF THE SKIN REACTION. THE REACTION WAS REPORTED AS THE SHAPE OF THE ELECTRODES. THE REACTION WAS REPORTED AS STARTING THE FIRST SIX DAYS OF THE ENROLLMENT PERIOD. THE ELECTRODES WERE NOT RETURNED TO (B)(6); THEREFORE, THE ELECTRODES ARE NOT AVAILABLE FOR EVALUATION BY CONMED CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35656 CLEARTRACE ADULT ECG ELECTRODE CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other