BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAMSUNG E FIT WATCH

    MDR report key: 11737522 · Received April 27, 2021

    Report

    Report Number
    MW5101028
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 24, 2021
    Manufacturer
    SAMSUNG ELECTRONICS CO., LTD., A BUSINESS OF MOBILE COMMUNIC
    Product Code
    QDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER PURCHASING A (B)(6) E FIT WATCH I HAVE NOTICED A RASH DEVELOPING WHICH WAS CAUSING IRRITATION AND DISCOMFORT. I HAVE HAD THE DEVICE OR 18 MONTHS BUT II NOTICE THE PROBLEM EARLIER THIS YEAR. THE PROBLEM HAD KEPT DEVELOPING EVEN AFTER CLEANING RUBBER STRAP AND DRESSING THE AFFECTED AREA. IT MADE NO DIFFERENCE AND STILL IT WAS STILL A PROBLEM. I HAVE PLACED COMPLAINT WITH (B)(6) AND RESPONSE SO FAR IS UNSATISFACTORY. I WAS UNDER THE IMPRESSION THAT RUBBER WAS HYPOALLERGENIC? BUT THEY INFORMED ME THAT THE STRAP MAY CONTAIN NICKEL. IT'S BEEN OVER 3 WEEKS SINCE I STOPPED WEARING DEVICE AND STILL HAVE DAMAGED SKIN, DISCOMFORT AND IRRITATION. MY INITIAL THOUGHTS THAT THE ELECTRONIC COMPONENTS WAS OMITTING HARMFUL RADIATION (TYPE) SYMPTOMS. IT IS A CONCERN AND WOULD LIKE AN INVESTIGATION INTO ITS FLAWS. IF THERE IS ANYTHING YOU CAN ASSIST WITH MY COMPLAINT IT WOULD BE APPRECIATED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631653 SAMSUNG E FIT WATCH ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA SAMSUNG ELECTRONICS CO., LTD., A BUSINESS OF MOBILE COMMUNIC SM R375

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other