BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIONET

    MDR report key: 7247504 · Received February 6, 2018

    Report

    Report Number
    MW5075105
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    February 3, 2018
    Report Date
    February 5, 2018
    Manufacturer
    CARDIONET, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS RECENTLY PRESCRIBED A 72 MONITOR WITH CARDIOKEY BY MY CARDIOLOGIST, DR. (B)(6). I RECEIVED THE CARDIOKEY (B)(6) 2018 AND BEGAN WEARING IT (B)(6) 2018. I WORE THE FIRST SET OF PATCHES BEGINNING THE MORNING OF (B)(6) 2018, AND CHANGED THEM ON THE EVENING OF (B)(6) 2018. WHEN I REMOVED THEM ON THE MORNING OF (B)(6) 2018, THE PATCHES HAD BURNED MY SKIN. I HAD ITCHY, PAINFUL, BLISTERED WELTS WHERE THE ELECTRODE PATCHES WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89383 CARDIONET AMBULATORY ECG MONITOR DSI CARDIONET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other