BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE ADULT ECG ELECTRODE

    MDR report key: 3268947 · Received August 7, 2013

    Report

    Report Number
    1320894-2013-00071
    Date Received
    August 7, 2013
    Report Date
    August 7, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    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, WAS NOT ACCOMPLISHED AS THE LOT NUMBER OF THE SUSPECT DEVICE WAS NOT MADE AVAILABLE. NO LABORATORY EXAMINATION WAS PERFORMED ON THE SUSPECT COMPLAINT DEVICE, AS NO DEVICE AND/OR NO PHOTOGRAPHS OF THE DEVICE OR SKIN REACTION WERE RETURNED TO CONMED COMPLAINT HANDLING CENTER FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT. THERE MAY BE A MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR END-USER RELATED. THE COMPLAINT CAN NEITHER BE CONFIRMED OR UNCONFIRMED AT THIS TIME. THIS COMPLAINT WAS RECEIVED IN THE FORM OF A LETTER DELIVERED TO CONMED CORPORATION THRU THE UNITED STATES POSTAL SERVICE. NO CONTACT INFORMATION (TELEPHONE NUMBER OR E-MAIL ADDRESS) WAS PROVIDED BY THE REPORTER. THE GENERAL PHONE NUMBER FOR THE HOSPITAL FACILITY WAS CALLED AND WE WERE UNABLE TO REACH THE REPORTING PHYSICIAN VIA THAT ROUTE. THEREFORE, A TECHNICAL DATA SHEET WAS MAILED TO THE PHYSICIAN AT THE DERMATOLOGY DEPARTMENT OF MEDSTAR WASHINGTON HOSPITAL CENTER TO ASSIST THE PHYSICIAN IN HIS PATCH TESTING OF THE PATIENT REGARDING THE INGREDIENTS FOUND WITHIN A CONMED CLEARTRACE ECG ELECTRODE. BASED ON THE MEDICAL DESCRIPTION OF THE EVENT PROVIDED BY THE PHYSICIAN, IT IS HIGHLY LIKELY THIS EVENT IS AN ALLERGIC REACTION TO THE ADHESIVE COMPONENT OF THE ECG ELECTRODES.. 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 ISO 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 THEIR DIAGNOSTIC UTILIZATION FOR CARDIAC MONITORING. THE UNANTICIPATED, SHORT-TERM SKIN REACTION IS A DIRECT RESULT OF AN ALLERGIC PATIENT REACTION TO AN ADHESIVE COMPONENT OF THE DEVICE, PER THE PHYSICIAN'S REPORT. 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. DEVICE NOT RETURNED TO CONMED CORP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CONMED CORPORATION IN A LETTER RECEIVED VIA THE USPS THAT, "I AM A PHYSICIAN WHO HAS A PATIENT WHO HAS DEMONSTRATED AN ALLERGIC CONTACT DERMATITIS TO THE ADHESIVE PORTION OF YOUR ADULT ECG ELECTRODE (REF (B)(4)). I WOULD APPRECIATE YOUR PROVIDING ME WITH EITHER A COMPLETE LIST OF INGREDIENTS IN THIS PRODUCT, OR MATERIALS SUITABLE FOR PATCH TESTING TO TRY TO DETERMINE THE SPECIFIC AGENT TO WHICH MY PATIENT IS ALLERGIC. I HAVE ALREADY DONE AN EXTENDED SCREENING SERIES OF PATCH TESTS WHICH INDICATE THAT THE PATIENT IS ALLERGIC TO SEVERAL DIFFERENT FRAGRANCE AGENTS AS WELL AS AMMONIATED MERCURY, ALTHOUGH I DOUBT THAT ANY OF THESE AGENTS ARE IN YOUR PRODUCT. I HAVE DONE A DIRECT USE TEST WITH THE PRODUCT AND THE PATIENT DEMONSTRATED ERYTHEMA AND VESICULATION WITHIN 48 HOURS OF APPLICATION. THEREFORE, I AM QUITE COMFORTABLE WITH THE DIAGNOSIS OF AN ALLERGIC CONTACT DERMATITIS. I WOULD APPRECIATE EITHER A COMPLETE LIST OF INGREDIENTS OR MATERIALS SUITABLE FOR PATCH TESTING WHICH CAN BE CODED IF YOU PREFER SO THAT I MAY IDENTIFY THE AGENT TO WHICH MY PATIENT IS ALLERGIC AND HELP HER AVOID IT IN THE FUTURE.." IT WAS NOT REPORTED WHETHER OR NOT THE PATIENT RECEIVED ANY MEDICAL TREATMENT FOR THE CONTACT DERMATITIS REPORTEDLY CAUSED BY A CONMED ECG DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370502 CLEARTRACE ADULT ECG ELECTRODE CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other