BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARTRACE CONDUCTIVE ADHESIVE ELECTRODE

    MDR report key: 1693859 · Received May 12, 2010

    Report

    Report Number
    1320894-2010-00064
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    March 5, 2010
    Report Date
    May 11, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO MFR. CONMED IS ATTEMPTING TO GATHER ADDITIONAL INFO SURROUNDING THIS INCIDENT. WHEN A QUALITY ENGINEERING EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PT "IN EMERGENCY ROOM ON (B)(6) 2010 ECG ELECTRODES PLACED ON HER FOR APPROX FIVE (5) TO SIX (6) HOURS. ON EVENING OF (B)(6) 2010 SHE NOTICED RED RINGS ON CHEST AND ABDOMEN, STAMP LIKE, NOT RAISED, NO ITCH, 4 AREAS. TWO (2) DAYS LATER, AT DERMATOLOGIST FOR UNRELATED ISSUE AND ASKED ABOUT THE MARKS. SHE WAS PRESCRIBED HYDROCORTISONE CREAM FOR A SKIN REACTION TO THE ECG ELECTRODES. IT TOOK APPROX 10 DAYS FOR THE REACTION TO CLEAR". PT WAS SENT THE PRIMARY CHEMICAL COMPONENTS OF THE ECG GEL AND BIOCOMPATABILITY SHEETS FOR HER REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARTRACE CONDUCTIVE ADHESIVE ELECTRODE CLEARTRACE ECG ELECTRODE DRX CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention