BEUDAMED
    FDA Adverse Event Summary report: N

    SURETRACE ADULT ECG ELECTRODE

    MDR report key: 3477378 · Received November 19, 2013

    Report

    Report Number
    1320894-2013-00119
    Date Received
    November 19, 2013
    Date of Event
    October 31, 2013
    Report Date
    January 8, 2014
    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

    LOT SAMPLES OF THE DEVICE HAVE BEEN RETURNED TO CONMED CORPORATION FOR EVALUATION. THE INVESTIGATION HAS NOT YET COMMENCED; HOWEVER, IS ANTICIPATED IN THE NEAR FUTURE. A SUPPLEMENTAL REPORT WILL BE FILED ON COMPLETION OF THE QUALITY ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    NO LOT NUMBERS WERE PROVIDED FOR THE ELECTRODES INVOLVED IN ANY OF THE REPORTED COMPLAINTS. REPRESENTATIVE SAMPLES OF THE ECG ELECTRODES WERE PROVIDED FOR TESTING (FOR SOME OF THE COMPLAINTS). IN TWO (2) CASES, USED ELECTRODES WERE PROVIDED TO CONMED. UNFORTUNATELY, ALL RETURNED ELECTRODES WERE COMPROMISED (EDGES FOLDED OVER OR ATTACHED TO POST IT NOTES WHERE DYE WAS ABSORBED INTO THE GEL) RENDERING THE ELECTRODES IN AN UNUSABLE CONDITION FOR TESTING PURPOSES. DURING A CONFERENCE CALL CONDUCTED ON (B)(6) 2013, THE FOLLOWING DETAILS WERE SHARED BY (B)(4). ALL CONMED ECG ELECTRODES ARE DEEMED BIOCOMPATIBLE FOR HUMAN USE ACCORDING TO EN ISO 10663-1: 2009 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES. ECG COMPONENTS (GEL AND SUBSTRATE MATERIALS) ARE TESTED FOR CYTOTOXICITY, SENSITIZATION, AND INTRACUTANEOUS FACTOR. A MANUFACTURING DEFECT THAT MAY LEAD TO SKIN REACTION IS REFERRED TO AS RESIDUAL MONOMER (UNCURED PRIMARY MONOMER IN THE HYDROGEL). THE PRESENCE OF LARGE AMOUNTS OF THE PRIMARY MONOMERS CONTAINED IN THE GEL MAY INCREASE THE PROBABILITY OF SKIN IRRITATION. A SPECTROPHOTOMETER TEST FOR RESIDUAL MONOMER WAS CONDUCTED ON RECENT LOTS OF ECG ELECTRODES CONTAINING THE 2000X GEL FORMULATION. TEST RESULTS SHOWED AN AVERAGE OF 0.51% MONOMER IN THE GEL COMPOSITION. THESE RESULTS ARE FAR BELOW THE WARNING LIMITS OF 3.0%. WITH RESPECT TO THE LOW RESIDUAL MONOMER COMPOSITION OF THE HYDROGEL AND THE RELATIVELY LOW INCIDENCES OF SKIN REACTIONS REPORTED FROM OTHER MEDICAL FACILITIES, PRODUCT RELATED ISSUES DO NOT APPEAR TO BE SIGNIFICANT. VARIOUS SKIN PREPARATION PRODUCTS WERE UTILIZED BY THE CRITICAL CARE UNITS AT THER UNIVERSITY OF ROCHESTER MEDICAL CENTER; SUCH AS, CAVILON, BATH-IN-A BAG, AND SKIN-PREP. EACH OF THESE CONTAIN A CHEMICAL BARRIER FILM, AND/OR, OILY SUBSTANCES SUCH AS VITAMIN E AND ALOE. THESE SOLUTIONS MAY HAVE BEEN TRAPPED UNDER THE ELECTRODE SITE, CAUSING A REACTION WITH THE GEL. THE INSTRUCTIONS FOR USE, IFU, SPECIFIES,"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." ADDITIONALLY, RAPID REMOVAL OF THE ELECTRODE MAY CAUSE SKIN DAMAGE. THE IFU ALSO INDICATES, "RAPID REMOVAL OF THE ELECTRODE FROM THE PATIENT MAY CAUSE SKIN DAMAGE." ANOTHER POSSIBLE CAUSE OF THE SKIN REACTIONS DOCUMENTED IN THE COMPLAINTS COULD BE BASED ON AN ALLERGIC REACTION TO A COMPONENT OF THE HYDROGEL OR SUBSTRATE ADHESIVES. THE POSSIBLE PRODUCT AND MANUFACTURING SOURCES FOR THESE EVENTS HAVE BEEN INVESTIGATED. A REVIEW OF THE MANUFACTURING PROCESS AND PRODUCT INSPECTION ALONG WITH SUBSEQUENT HYDROGEL ANALYSIS HAS SHOWN NO SIGNIFICANT CHANGES TO PROCESS OR MATERIALS. THESE RESULTS, IN CONJUNCTION WITH DISCUSSIONS WITH UNIVERSITY OF ROCHESTER MEDICAL CENTER STAFF, SUGGEST THAT THIS UNCHARACTERISTIC INCREASE IN SKIN REACTION EVENTS MAY BE ATTRIBUTABLE TO SKIN PREPARATION WITHIN THE ADULT CRITICAL CARE UNITS; PRIMARILY THE USE OF THE ABOVE MENTIONED PRODUCTS: CAVILON, BATH-IN-A BAG, AND SKIN-PREP. 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 SIX (6) REPORTED SKIN IRRITATIONS/REACTIONS WITH THIS COMPLAINT. THEREFORE, THIS MEDWATCH IS ASSOCIATED WITH THE FOLLOWING MEDWATCH REPORTS: 1320894-2013-00119; 1320894-2013-00128; 1320894-2013-00129; 1320894-2013-00130; 1320894-2013-00131; AND, 1320894-2013-00132.

    Description of Event or Problem · 1

    IT WAS REPORTED, "1800-030 - "NEW PATIENT SHOWING BLISTERING UNDER WHERE ELECTRODES HAD BEEN PLACED. UNCLEAR OF PATIENT STATUS OR TREATMENT OF INJURY. CONTACT (B)(6) FOR RETRIEVAL OF ELECTRODES FROM THE SAME DRAWER. SHE REPORTED TO ME THAT SHE SAVED THEM." FURTHER COMMUNICATIONS REVEALED THAT THE SKIN REACTION IS BEING TREATED WITH POLYSPORIN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599078 SURETRACE ADULT ECG ELECTRODE SURETRACE ECG ELECTRODE DRX CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other