BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITBIT CHARGE 2

    MDR report key: 8960285 · Received September 3, 2019

    Report

    Report Number
    MW5089523
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 28, 2019
    Report Date
    August 30, 2019
    Manufacturer
    FITBIT, INC.
    Product Code
    PUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE SLEEPING, I WAS AWOKEN BY A STRONG ELECTRICAL SHOCK COMING FROM MY FITBIT CHARGE 2 WATCH. IT WAS MORE THAN A STATIC ELECTRICAL SHOCK, BUT LESS THAN A 110 OUTLET SHOCK. IT LASTED FOR SEVERAL SECONDS AND DIDN'T LEAVE ANY BURN MARKS ON MY WRIST. I AM NOW AFRAID TO WEAR THIS WATCH BECAUSE OF FEAR THAT IT MIGHT HAPPEN WHILE I AM DRIVING. LOOKED UP FITBIT COMPLAINT LINE AND THEY BLAME SHOCKS FROM STATIC ELECTRICITY. I COULD SEE STATIC HAPPENING IN THE WINTER MONTHS, BUT NOT IN THE SUMMER MONTHS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750764 FITBIT CHARGE 2 ANALYZER, BODY COMPOSITION EXEMPT PUH FITBIT, INC. FITBIT 2 CHARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other