BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARTRACE ECG MONITORING ELECTRODE

    MDR report key: 381381 · Received March 11, 2002

    Report

    Report Number
    1317214-2002-00013
    Event Type
    Other
    Date Received
    March 11, 2002
    Date of Event
    January 12, 2001
    Report Date
    February 11, 2002
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT, " THIRTEEN MONTHS AFTER A STRESS TEST, PT CONTINUES TO HAVE HYPERPIGMENTATION OF THE SKIN ON THEIR RIB AND CHEST AREAS (5 MARKS) WHERE THE ECG ELECTRODES HAD BEEN PLACED".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other