BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARTRACE 2 LT

    MDR report key: 352398 · Received September 21, 2001

    Report

    Report Number
    1317214-2001-00037
    Event Type
    Injury
    Date Received
    September 21, 2001
    Date of Event
    August 23, 2001
    Report Date
    August 23, 2001
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ECG ELECTRODES WERE USED ON A PT UNDERGOING AN MRI PROCEDURE. THE PT RECEIVED 3RD DEGREE BURNS AT THE ELECTRODE SITES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43190 CLEARTRACE 2 LT ECG MONITORING ELECTRODES DRX CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention