WHOOP 4.0
Received Oct 20, 2025 · Event occurred Oct 7, 2025
Report MW5177669 · MDR key 23342636
Device
Generic name
Electrocardiograph Software For Over-the-counter Use
Manufacturer
Whoop, Inc.Catalog number
W//4C2814134
Product problems
- Patient-Device Incompatibility
Patient
34 YR · Male
- Erythema
- Discomfort
- Skin Inflammation/ Irritation
- Erythema
- Discomfort
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
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.