BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHOOP WEARABLE ARMBAND

    MDR report key: 21084826 · Received January 6, 2025

    Report

    Report Number
    MW5164321
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    December 22, 2024
    Report Date
    December 25, 2024
    Manufacturer
    WHOOP
    Product Code
    QZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS PERTAINING TO THE WHOOP WEARABLE ARM BAND. IT BURNT MY ARM TWICE, WITH NO RESPONSE OR ADVISE ABOUT SOLUTIONS FROM THE MANUFACTURER. THESE ARE NOT SERIOUS BURNS THAT REQUIRE HOSPITALIZATION, BUT THEY ARE SERIOUS ENOUGH THAT I HAD TO TAKE IT OFF, AND USE OTC BURN CREAM FOR A WEEK OR SO BEFORE IT HEELED ENOUGH TO NOT BE PAINFUL TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351891 WHOOP WEARABLE ARMBAND OVER-THE-COUNTER DEVICE TO ASSESS RISK OF SLEEP APNEA QZW WHOOP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention FREESTYLE LIBRE.| METFORMIN.