BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITBIT VERSA

    MDR report key: 8894344 · Received August 13, 2019

    Report

    Report Number
    MW5089033
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    August 1, 2019
    Manufacturer
    FITBIT, INC.
    Product Code
    PUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER I STARTED USING THE FITBIT VERSA DEVICE, I BEGAN EXPERIENCING SHARP PAINS FROM MY LEFT WRIST UP THROUGH MY LEFT SHOULDER, ALONG WITH RESTRICTED RANGE OF MOTION AS A RESULT OF THE PAIN AND NERVE IRRITATION. AS SOON AS I STOPPED WEARING THE DEVICE, THE PAIN SUBSIDED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684118 FITBIT VERSA ANALYZER, BODY COMPOSITION EXEMPT PUH FITBIT, INC. FBS04

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR