BEUDAMED
    FDA Adverse Event Summary report: N

    SURETRACE ADULT ECG ELECTRODE

    MDR report key: 3523278 · Received December 17, 2013

    Report

    Report Number
    1320894-2013-00129
    Date Received
    December 17, 2013
    Date of Event
    November 22, 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

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICES FROM TWO SEPARATE INCIDENTS HAVE BEEN RETURNED TO CONMED CORPORATION FOR EVALUATION, IN THE SAME PACKAGE. THESE TWO WILL BE EVALUATED TOGETHER AS ONE INVESTIGATION REPORT. 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. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 1320894-2013-00128.

    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. (B)(4). 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 - I HAVE NOT RECEIVED THE BIOKIT YET, BUT WAS HANDED MORE ELECTRODES FROM (B)(6) 2013, WHEN BLISTERS ON THE PATIENTS SKIN WERE FOUND UNDERNEATH THE GEL. I HAVE SIX LEADS - FIVE FROM ONE PATIENT (BUT THEY DID NOT INDICATE WHICH ONE OF THE FIVE WAS THE PROBLEM) AND ONE FROM ANOTHER." SKIN IRRITATIONS WERE TREATED WITH ANTIBIOTIC OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659274 SURETRACE ADULT ECG ELECTRODE SURETRACE ECG ELECTRODE DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other