BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO V ELECTRODE

    MDR report key: 758262 · Received September 7, 2006

    Report

    Report Number
    1225215-2006-00001
    Event Type
    Injury
    Date Received
    September 7, 2006
    Date of Event
    August 17, 2006
    Report Date
    August 31, 2006
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED BASED ON INFO PROVIDED BY THE PT/NURSE. THE SPECIFIC ELECTRODES USED WERE DISCARDED. THE REMAINING ELECTRODES NOT USED FROM THE SAME PACKAGE ARE BEING RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW UP REPORT TO THIS MDR WILL BE FILED UPON COMPLETION OF THE EVENT INVESTIGATION.

    Description of Event or Problem · 1

    SUBJECT WAS AN R.N. PARTICIPATING IN A TRAINING SESSION USING THE CAMBRIDGE HEART MICRO-V ELECTRODES. SHE WAS PREPPED BY TWO PEOPLE, A CLINICAL SPECIALIST FROM THE CO. AND A TRAINEE (CUSTOMER'S MED STAFF) AND THE TEST WAS UNEVENTFUL. UPON REMOVAL OF THE ELECTRODES, SAME SKIN IRRITATION WAS NOTED. APPROX 28 HRS LATER, THE SUBJECT DECIDED TO SEE AN URGENT CARE PHYSICIAN FOR TREATMENT OF THE SKIN REACTION WHERE IRRITATION FROM THE ELECTRODES WAS OBSERVED. THE URGENT CARE PHYSICIAN REPORTEDLY CLASSIFIED THE IRRITATION AS CONTACT DERMATITIS/CHEMICAL BURN. SUBJECT WAS RELEASED BY THE URGENT CARE PHYSICIAN WHO RECOMMENDED OTC TOPICAL PRODUCTS. NO OTHER MED INTERVENTION WAS REPORTED. SUBJECT IS CONCERNED ABOUT THE POSSIBILITY OF A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO V ELECTRODE ELECTRODE ELECTROCARDIOGRAPH JOS CAMBRIDGE HEART, INC. NA 538164

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R