BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHOOP 4.0

    MDR report key: 23342636 · Received October 20, 2025

    Report

    Report Number
    MW5177669
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 15, 2025
    Manufacturer
    WHOOP, INC.
    Product Code
    QDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SUBJECT: REPORT OF SKIN IRRITATION CAUSED BY WHOOP 4.0 FITNESS BAND DEAR SIR/MADAM, I AM WRITING TO FORMALLY REPORT A HEALTH-RELATED ISSUE I EXPERIENCED WHILE USING THE WHOOP 4.0 FITNESS BAND, WHICH I PURCHASED THROUGH FLIPKART INDIA (AN AUTHORIZED MARKETPLACE). WITHIN 3¿4 DAYS OF INITIAL USE, I DEVELOPED SKIN IRRITATION, REDNESS, AND DISCOMFORT AT THE SITE WHERE THE DEVICE WAS WORN. DESPITE ADHERING STRICTLY TO THE MANUFACTURER'S CARE INSTRUCTIONS--INCLUDING REGULAR CLEANING, ENSURING THE BAND WAS COMPLETELY DRY BEFORE WEARING, AND SUBSEQUENTLY AVOIDING ITS USE DURING BATHING¿THE IRRITATION PERSISTED AND PROGRESSIVELY WORSENED. HOWEVER, BASED ON MY EXPERIENCE, THE SYMPTOMS ARE CONSISTENT WITH A CONTACT REACTION TO THE MATERIAL OR COATING OF THE BAND OR SENSOR BASE. THE CONDITION HAS CAUSED SIGNIFICANT SKIN DISCOMFORT AND RAISES A POTENTIAL HEALTH AND SAFETY CONCERN FOR OTHER USERS WHO MAY EXPERIENCE SIMILAR REACTIONS. I AM PROVIDING THIS INFORMATION SO THAT IT MAY BE APPROPRIATELY REVIEWED AS A POSSIBLE PRODUCT-RELATED DERMATOLOGICAL ADVERSE EVENT. PLEASE LET ME KNOW IF ANY ADDITIONAL DETAILS, PHOTOGRAPHS, OR DOCUMENTATION ARE REQUIRED TO SUPPORT THIS REPORT. SINCERELY, (B)(6). NO TEST DONE BUT IMAGES ARE THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452533 WHOOP 4.0 ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA WHOOP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Life Threatening| R