BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3-M RED DOT MONITORING ELECTRODE

    MDR report key: 85512 · Received July 1, 1996

    Report

    Report Number
    85512
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    January 29, 1996
    Report Date
    February 26, 1996
    Manufacturer
    3-M HEALTHCARE
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    MRI WAS PERFORMED ON PT ON 1/29/96. PT WAS SEDATED FOR MRI. NON-INVASIVE CARDIAC MONITOR PLACED ON PT. ELECTRODES WERE USED WITH CARDIAC MONITOR. FOUR ELECTRODES PLACED ON PT. IMMEDIATELY POST-MRI ELECTRODES WERE REMOVED AND PT'S SKIN WAS ASSESSED: 3 SLIGHTLY REDDENED AREAS THE SIZE OF THE ELECTRODE WERE NOTED AND THE FOURTH ELECTRODE LEAD AREA WAS BLISTERED. THE BLISTER WAS THE SIZE OF A DIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-M RED DOT MONITORING ELECTRODE MONITORING ELECTRODES DRX 3-M HEALTHCARE 2255-3 203

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention NON INVASIVE VITAL SIGN OMNI-TRAK CARDIAC MONITOR