BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACE-RITA SILVER/SILVER CHLORIDE ECG MONITORING

    MDR report key: 926140 · Received October 7, 2007

    Report

    Report Number
    MW5004007
    Event Type
    Injury
    Date Received
    October 7, 2007
    Date of Event
    September 29, 2007
    Report Date
    October 7, 2007
    Manufacturer
    BIO-DETEK INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SERIES OF TRACE-RITE SILVER/SILVER CHLORIDE DISPOSABLE ECG MONITORING ELECTRODES WERE PLACED ON THE ABDOMEN AND CHEST OF THE PT FOR AN ELECTIVE STRESS ECHO CARDIAC TEST. THE NEXT DAY, 24 HRS LATER, PT PRESENTED WITH SEVERE CONTACT DERMATITIS IN THE EXACT LOCATION OF THE ELECTRODES. THE SKIN WAS INDURATED AND ERYTHEMATOUS, AND DEMONSTRATED ARCUATE AND ANNULAR PROFILES CORRESPONDING TO THE ADHESIVE COATED SURFACE OF THE ROUND FOAM ELECTRODES. THERE WERE NO REACTION TO THE GEL USED ON THE WAND USED FOR THE ECHO. FREQUENCY: 1X. ROUTE: CUTANEOUS. DIAGNOSIS OR REASON FOR USE: SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACE-RITA SILVER/SILVER CHLORIDE ECG MONITORING ECG ELECTRODES ADULT FOAM ROUND DRX BIO-DETEK INC. P/N ME405 ME405

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other