BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERMED ECG MONITORING ELECTRODES

    MDR report key: 7780311 · Received August 13, 2018

    Report

    Report Number
    MW5079121
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 22, 2018
    Report Date
    August 9, 2018
    Manufacturer
    NISSHA FIS, INC
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS WEARING A 30 DAY HEART MONITOR AND THE LEADS MADE LARGE BURNS ON MY SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620377 VERMED ECG MONITORING ELECTRODES ELECTRODE ELECTROCARDIOGRAPH DPS NISSHA FIS, INC 50117V13

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR