BEUDAMED
    FDA Adverse Event Summary report: N

    SURETRACE ADULT ECG ELECTRODE

    MDR report key: 3429494 · Received October 25, 2013

    Report

    Report Number
    1320894-2013-00108
    Date Received
    October 25, 2013
    Report Date
    October 25, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURETRACETRACE 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 POSSIBLE AS THE LOT NUMBERS WERE NOT MADE AVAILABLE. THERE COULD BE MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED ISSUES FOR THIS FAILURE MODE. THESE ELECTRODES ARE TESTED AND PASSED FOR BIOCOMPATIBILITY. SURETRACE ELECTRODES, GEL AND THE BASE PAD, BOTH MATERIALS ARE TESTED FOR CYTOTOXICITY, SENSITIZATION, AND INTRACUTANEOUS FACTOR PER ISO APPROVED TESTING. IT IS POSSIBLE THAT THE PATIENT HAD SOLVENTS UNDER THE ELECTRODE SITE SUCH AS THAT SKIN SOAP WHICH COULD HAVE CAUSED THE IRRITATION. IFU 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." A RAPID REMOVAL OF THE ELECTRODE COULD SKIN DAMAGE. IFU INDICATES, "RAPID REMOVAL OF THE ELECTRODE FROM THE PATIENT MAY CAUSE SKIN DAMAGE." NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE PRODUCT. NO VISUAL EVIDENCE OF REACTION/BLISTERS WAS PROVIDED BY THE END USER (I.E. THROUGH PICTURES OR PRODUCTS). THE COMPLAINT FAILURE MODE IS INCONCLUSIVE. POSSIBLE CAUSE OF THE FAILURE MODE COULD BE IMPROPER SKIN SITE PREPARATION, OR, RAPID REMOVAL OF THE ELECTRODES. ANOTHER POSSIBLE CAUSE OF THE SKIN REACTIONS IS A PATIENT ALLERGIC REACTION TO THE GEL OR ADHESIVE COMPONENT OF THE DEVICE. THE SURETRACE 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 THE CLINICAL UTILIZATION OF CARDIAC MONITORING. NO CONCLUSIVE MANUFACTURING RELATED DEFECTS WERE OBSERVED WITH THE DEVICES DURING THE EVALUATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THERE WERE THIRTEEN (13) REPORTED SKIN IRRITATIONS/REACTIONS WITH THIS COMPLAINT. THEREFORE, THIS MEDWATCH IS ASSOCIATED WITH THE FOLLOWING MEDWATCH REPORTS: 1320894-2013-00096; 1320894-2013-00097; 1320894-2013-00098; 1320894-2013-00099; 1320894-2013-00100; 1320894-2013-00101; 1320894-2013-00102; 1320894-2013-00103; 1320894-2013-00104; 1320894-2013-00105; 1320894-2013-00106; 1320894-2013-00107; AND, 1320894-2013-00108. DEVICES DISCARDED BY END-USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED, "1800-030 - I WAS INFORMED YESTERDAY OF A CONTINUING PROBLEM WITH THE 1800-030. SINCE (B)(6) 2012 THERE HAVE BEEN 13 PATIENT INJURIES REPORTED IN THE (B)(6) REPORTING SYSTEM. THERE HAVE 5 REPORTS OF INJURIES IN 2013. THESE INJURIES ARE BEING REPORTED AS BLISTERING ON THE SKIN OF PATIENTS UNDERNEATH THE AREA COVERED BY THE 1800-030 ELECTRODE. THE BLISTERS ARE YELLOW PUS FILLED OR A DARK PURPLE. THE MAJORITY OF BLISTERS WERE ON ELDERLY PATIENTS BUT THERE WERE ALSO REPORTS OF THIS ISSUE ON A ADOLESCENT/PEDIATRIC PATIENT. THE TYPICAL LOCATION OF THE BLISTER WAS AT THE RA AND LA PLACEMENT. APPROPRIATE WOUND CARE USED TO ADDRESS BLISTERING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548048 SURETRACE ADULT ECG ELECTRODE SURETRACE ECG ELECTRODE DRX CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other