BEUDAMED
    FDA Adverse Event Summary report: N

    CLEARTRACE ADULT ECG ELECTRODES

    MDR report key: 2097518 · Received May 20, 2011

    Report

    Report Number
    1320894-2011-00052
    Date Received
    May 20, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO THE MANUFACTURER. FROM THE PHOTOGRAPH THIS IS A MINOR SKIN IRRITATION/REACTION. WHEN A QUALITY ENGINEERING EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. THIS COMPLAINT WAS REPORTED AS THREE (3) PATIENTS HAVING AN ALLERGIC REACTION TO CLEARTRACE ECG ELECTRODES. THE THREE (3) ASSOCIATED MEDWATCH REPORTS ARE AS FOLLOWS: 1320894-2011-00051, 1320894-2011-00052, AND, 1320894-2011-00053. RETAINED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    THE CLEARTRACE ECG ELECTRODES WERE RETAINED BY THE END-USER; THEREFORE, AN EVALUATION ON THE SUSPECT DEVICE CANNOT BE COMPLETED. THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW FOR LOT NUMBER 1001043, THE MANUFACTURING DOCUMENTS HAVE VERIFIED 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. 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." 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 SUSPECT PRODUCT. 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; THUS, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. (B)(4): DEVICE RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THREE (3) PATIENTS GET ALLERGY FROM CLEARTRACE ECG ELECTRODE." NO SPECIFIC SYMPTOMS OF THE ALLERGIC REACTION WERE REPORTED; HOWEVER, PHOTOGRAPH SHOWED REDNESS OF EPIDERMIS UNDER GEL PORTION OF ECG ELECTRODE. REPORT FROM NURSE STATES THEY UTILIZED AN ANTI-ALLERGY CREAM ON ALL THREE (3) OF THE REACTIONS. THE EVENT OCCURRED AT THE (B)(6) HOSPITAL. THE HOSPITAL IS RETAINING THE SUSPECT PRODUCTS; THEREFORE, THE ELECTRODES ARE NOT AVAILABLE FOR EVALUATION BY CONMED CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARTRACE ADULT ECG ELECTRODES CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION 1001043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention