BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODE

    MDR report key: 2027960 · Received March 23, 2011

    Report

    Report Number
    1320894-2011-00022
    Date Received
    March 23, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO CONMED CORPORATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE QUALITY ENGINEERING INVESTIGATION IS COMPLETED. DEVICE DISCARDED BY END-USER.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO MANUFACTURER FOR EXAMINATION OR CONFIRMATION OF DEFECT. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR SKIN IRRITATION HAS SHOWN TWELVE (12) PREVIOUS COMPLAINTS. A REVIEW OF THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, FOR LOT NUMBER 1101283 HAS VERIFIED THAT 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. THIS PRODUCT WAS UTILIZED BY THE END-USER WITH A LIFE-TECH, INC., MODEL ES400, EZSTIM II, PERIPHERAL NERVE LOCATOR AND STIMULATOR. NEURO-MUSCULAR STIMULATION IS AN OFF LABEL USE FOR THIS PRODUCT. ACCORDING TO THE IFU, INSTRUCTIONS FOR USE, THIS SINGLE USE DISPOSABLE DEVICE IS "INTENDED FOR USE DURING ELECTROCARDIOGRAPHIC (ECG) PROCEDURES". THESE ECG ELECTRODES ARE USED AS AN ELECTRICAL CONDUCTOR WHEN APPLIED TO A PATIENT'S SKIN TO TRANSMIT ELECTRICAL SIGNALS FOUND AT THE BODY'S SURFACE TO A MONITOR, FOR THE DIAGNOSIS OF AILMENTS BY HEALTH CARE PROFESSIONALS. PER CONMED'S HAZARD AND RISK ANALYSIS DOCUMENT FOR ECG ELECTRODES, WHEN EXPLORING THE ISSUE OF WHETHER ENERGY IS DELIVERED OR TAKEN FROM THE PATIENT WITH THIS DEVICE, THE DOCUMENT ANSWERS, "NO, ENERGY IS NEITHER DELIVERED OR TAKEN FROM THE PATIENT." PER THE OPERATOR'S MANUAL FOR THE LIFE-TECH, INC., MODEL ES400, EZSTIM II, PERIPHERAL NERVE LOCATOR AND STIMULATOR THE ELECTRICAL NERVE STIMULATION ENERGY DELIVERED TO THE PATIENT (OUTPUT CURRENT) RANGES FROM 0.05MA TO 5.0MA IN THE LOW OUTPUT RANGE, AND, FROM 0.05MA TO 80 MA IN THE HIGH OUTPUT RANGE. THE RISK TO THE PATIENT HAS NOT BEEN ANALYZED BY CONMED REGARDING THE USE OF THE ECG ELECTRODE AS A CONDUCTOR FOR THE DELIVERY OF ELECTRICAL NERVE STIMULATION TO THE PATIENT. BIOCOMPATIBILITY DOCUMENTS NOTE THAT ALL SKIN CONTACT SUBSTANCES WERE TESTED AND ARE CONSIDERED BIOCOMPATIBLE FOR THEIR INTENDED USE. ELECTRODES WERE TESTED FOR CYTOTOXICITY, AND, SENSITIZATION AND IRRITATION THROUGH ISO TESTING; THEREFORE, THE LIKELIHOOD OF REACTION DUE TO MANUFACTURING RELATED ISSUES IS RELATIVELY LOW. MANUFACTURING DEFECTS WERE NOT IDENTIFIED WITHIN THE EVALUATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE DISCARDED BY END-USER.

    Additional Manufacturer Narrative · 1

    I FAILED TO REPORT DATE RECEIVED BY MANUFACTURER WITH ORIGINAL SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "CLEARTRACE ELECTRODE CAUSING REDNESS TO PATIENT'S SKIN, BURN WITHOUT BLISTERS, NO TREATMENT USED. NEUROMUSCULAR APPLICATION." ADDITIONAL INFORMATION RECEIVED FROM END-USER, "CLEAR TRACE ELECTRODES USED WITH A TWITCH MONITOR, MANUFACTURER LIFE TECH, MODEL ES400." MANUFACTURED BY LIFE-TECH, INC. MODEL ES400 IS A EZSTIM II, PERIPHERAL NERVE LOCATOR AND STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARTRACE CONDUCTIVE ADHESIVE GEL ADULT ECG ELECTRODE CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION 1101283

    Patients

    Seq Age Sex Outcome Treatment
    1