BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRATRACE WET GEL ADULT ECG ELECTRODE

    MDR report key: 2571968 · Received May 11, 2012

    Report

    Report Number
    1320894-2012-00031
    Date Received
    May 11, 2012
    Date of Event
    April 4, 2012
    Report Date
    June 5, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K905446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    I APOLOGIZE FOR THE LATE FILING OF THIS EVENT. BEING RECEIVED BY CONMED ON (B)(4) 2012, THIS SHOULD HAVE BEEN TO YOUR FACILITY BY (B)(4) 2012. THE DEVICE IS NOT BEING RETURNED TO CONMED CORPORATION FOR EVALUATION. PHOTOGRAPHS HAVE BEEN SENT OF THE SKIN IRRITATION. WHEN THE QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. AGAIN, I APOLOGIZE FOR THIS LATE SUBMISSION. DEVICE NOT RETURNED TO CONMED CORP.

    Additional Manufacturer Narrative · 1

    THE ULTRATRACE ECG ELECTRODE IS AN ELECTROCARDIOGRAPH ELECTRODE IS 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. DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW COULD NOT BE ACCOMPLISHED AS THE LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. ONE (1) USED DEVICE WAS RETURNED TO CONMED COMPLAINT CENTER FOR INVESTIGATION. THE RETURNED DEVICE WAS EXAMINED IN THE LABORATORY. THERE WAS A BLUE CONTAMINANT OBSERVED ON THE ON THE ELECTRODE (ON GEL AND ADHESIVE AREAS). THIS CONTAMINATION WAS MOST LIKELY AFTER PRODUCTION FOR THERE IS NOTHING ON THE PRODUCTION LINE THAT COULD CAUSE THIS TYPE OF CONTAMINATION. THIS CONTAMINATION WAS MOST LIKELY PICKED UP ON THE ELECTRODE AFTER PATIENT USE. 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. 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. PICTURES OF THE SKIN IRRITATION WERE RETURNED TO CONMED CORPORATION. THE SKIN REACTION APPEARS TO HAVE OCCURRED BOTH WHERE THE GEL AND THE ADHESIVE OF THE ECG ELECTRODE COMES IN CONTACT WITH THE PATIENT'S SKIN SURFACE. THE RASH EXTENDS PAST THE ECG CONTACT AREA AND APPEARS TO BE A RED, RAISED RASH. FROM THE APPEARANCE OF THE SKIN RASH AND INFORMATION FROM THE DERMATOLOGIST, THE PATIENT MOST PROBABLY EXPERIENCED AN ALLERGIC RESPONSE TO A COMPONENT OF THE DEVICE SUCH AS ELECTRODE GEL AND/OR ADHESIVE. THIS ALSO HAPPENED TO THIS PATIENT (SKIN REACTION FROM ECG ELECTRODES IN 2009, FROM ECG DIAGNOSTIC MONITORING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED," ON (B)(6) 2012, MY DAUGHTER WAS PLACED ON A 24 HOUR HOLTER MONITOR THAT INCLUDED ULTRATRACE 1690 LEADS. WE PROMPTLY REMOVED THE LEADS 24 HOURS LATER AND MY DAUGHTER WAS LEFT WITH A NASTY RASH." THIS WAS A RED SKIN RASH IN THE SHAPE OF THE ECG ELECTRODES ULTRATRACE ECG ELECTRODES (CATALOG NUMBER UNKNOWN {1690-???}, LOT NUMBER UNKNOWN) WERE POTENTIALLY UTILIZED. THE PATIENT REPORTED AN OFFICE CONSULT WITH A MEDICAL PROFESSIONAL FOR TREATMENT OF THE SKIN IRRITATION. A PRESCRIPTION STEROID CREAM WAS PRESCRIBED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATRACE WET GEL ADULT ECG ELECTRODE ULTRATRACE ECG ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other