BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRAC ADULT ECG ELECTRODE

    MDR report key: 2170537 · Received July 21, 2011

    Report

    Report Number
    1320894-2011-00056
    Date Received
    July 21, 2011
    Report Date
    July 18, 2011
    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

    IT IS UNKNOWN WHETHER CONMED CLEARTRACE ECG ELECTRODES WERE EVER UTILIZED ON THE PATIENT WITH THE SUSPECT SKIN IRRITATION FOR THE PATIENT COULD NOT RECALL THE TYPE OF ELECTRODES UTILIZED PER LIFEWATCH SERVICES, INC. THE PATIENT DID REPORT SEEING HER DERMATOLOGIST FOR TREATMENT OF THE SKIN IRRITATION; HOWEVER, IT IS UNKNOWN WHETHER ANY TREATMENT WAS GIVEN OR ANY MEDICATION OR TREATMENTS PRESCRIBED. DESPITE LACK OF ANY KNOWLEDGE REGARDING TREATMENT REGIME; CONMED HAS DECIDED TO REPORT THIS INCIDENT FOR THE END-USER WAS "SEEN BY HER DERMATOLOGIST FOR TREATMENT". THE CLEARTRACE ECG ELECTRODES THAT WERE INITIALLY DELIVERED TO THE END-USER WERE DISCARDED; THEREFORE, AN INVESTIGATION ON THE SUSPECT DEVICE CANNOT BE COMPLETED. THE LOT NUMBER OF THE ELECTRODES INITIALLY DELIVERED IS UNKNOWN THEREFORE A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW CANNOT BE ACCOMPLISHED. THE PATIENT DECLINED TO ANSWER ANY QUESTIONS SURROUNDING THE INCIDENT PER LIFEWATCH SERVICES, INC.. IT IS UNKNOWN HOW THE END-USER PREPARED THE ECG SITE PRIOR TO USE. THE IFU, INSTRUCTIONS FOR USE, STATE, "FOR OILY SKIN, CLEANSE WITH ALCOHOL PAD AND LET DRY COMPLETELY BEFORE APPLYING ELECTRODE. PREPARE SITE WITH A BRISK, DRY RUB. AVOID DAMAGE OR ABRASION OF SKIN SURFACE." THERE COULD BE A MULTIPLE OF POSSIBLE CAUSES FOR THIS COMPLAINT. ONE POSSIBLE CAUSE COULD BE INSUFFICIENT SKIN PREPARATION RESULTING IN TRAPPED SOLVENTS OR OIL UNDER THE ELECTRODE. THE IFU SPECIFIES THAT "THE ELECTRODE SITE SHOULD BE DRY BEFORE ELECTRODE APPLICATION. TRAPPED SOLVENTS CAN CAUSE SKIN IRRITATION AND LOSS OF ADHESION." STORAGE CONDITIONS CAN ALSO AFFECT THE GEL OF THE ELECTRODES WHICH MAY BE ANOTHER POSSIBLE CAUSE OF THIS INCIDENT. THE IFU STATES THAT THE, "ELECTRODES SHOULD NOT BE UTILIZED IF THE GEL IS DRIED OUT. AVOID STORAGE OF ELECTRODES WHERE THEY MAY BE SUBJECT TO EXCESSIVE HEAT OR COLD. ELECTRODES SHOULD BE STORED IN UNOPENED POUCHES AT ROOM TEMPERATURE." FURTHERMORE, ALLERGIC REACTION TO GEL COMPONENT OR ADHESIVE COULD BE A POSSIBLE CAUSE FOR THIS FAILURE MODE. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME; ESPECIALLY WITHOUT EXAMINATION OF THE PRODUCT OR REVIEW OF THE DHR/LHR DOCUMENTS. BIOCOMPATIBILITY DOCUMENTS NOTED 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. THUS, LIKELY POSSIBILITY OF REACTION DUE TO MANUFACTURING RELATED ISSUE 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 NEVER RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT COMPLAINT THAT SUPPOSEDLY INVOLVED CONMED ELECTRODES USED IN CONJUNCTION WITH THE ACT III SENSOR. THE CARDIAC MONITORING ENROLLMENT PERIOD WAS SCHEDULED FOR (B)(6) 2011 THROUGH (B)(6) 2011. THE PATIENT CALLED TO REPORT A SKIN IRRITATION FROM ECG ELECTRODES. THE PATIENT REPORTED ITCHING, BLEEDING, RAWNESS, PAIN, AND BROKEN SKIN." NO ELECTRODES HAVE BEEN RETURNED TO LIFEWATCH; HOWEVER, CLEARTRACE ECG ELECTRODES (CATALOG NUMBER 1700-005, LOT NUMBER NOT AVAILABLE) WERE POTENTIALLY UTILIZED. CLEARTRACE ECG ELECTRODES WERE INCLUDED IN THE KIT DELIVERED TO THE PATIENT YET THE PATIENT COULD NOT RECALL THE ELECTRODE TYPE THAT HAD BEEN UTILIZED IN THE CARDIAC MONITORING PERIOD. THE PATIENT REPORTED SEEING HER DERMATOLOGIST FOR TREATMENT OF THE IRRITATION. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION OR ANY TYPE OF TREATMENT FOR THE REPORTED SKIN IRRITATION. NO PHOTOGRAPHS ARE AVAILABLE OF THE REPORTED SKIN IRRITATIONS. LIFEWATCH SERVICES, INC., ATTEMPTED TO CONDUCT A PATIENT TELEPHONE SURVEY SURROUNDING THE DETAILS OF THE INCIDENT; HOWEVER, THE PATIENT DECLINED TO ANSWER ANY OF THE QUESTIONS PRESENTED TO HER BY LIFEWATCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other