KT RECOVERY + ICE HEAT MASSAGE BALL
Report
- Report Number
- 3007282994-2025-00003
- Event Type
- Injury
- Date Received
- December 23, 2025
- Date of Event
- November 22, 2025
- Report Date
- December 23, 2025
- Manufacturer
- KT HEALTH, LLC
- Product Code
- IME
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
REPORTABLE INJURY IDENTIFIED. INVESTIGATION IN PROGRESS.
THIS SPONTANEOUS REPORT FROM THE U.S. WAS RECEIVED ON 24-NOV-2025 REGARDING A 42-YEAR-OLD MALE IN ASSOCIATION WITH THE KT RECOVERY + ICE HEAT MASSAGE BALL. APPROXIMATELY ON (B)(6) 2025, THE CONSUMER FIRST USED THE PRODUCT AND APPLIED IT TO HIS BACK WITHOUT ISSUE. ON (B)(6) 2025, THE CONSUMER USED THE PRODUCT FOR THE SECOND TIME. AFTER HEATING THE PRODUCT IN THE MICROWAVE FOR 15 SECONDS, THEN REHEATING FOR ANOTHER 15 SECONDS, HE RETRIEVED THE PRODUCT FROM THE MICROWAVE. AFTER TAKING SEVERAL STEPS, HE NOTED THE PRODUCT DISCHARGED HEATED GEL OVER HIS CHEST AND STOMACH. HE WENT TO THE EMERGENCY ROOM (ER) WHERE HE REPORTED HE WAS DIAGNOSED WITH FIRST, SECOND, AND THIRD DEGREE BURNS DUE TO CONTACT WITH THE HEATED GEL. HE NOTED IT WAS PAINFUL AND SKIN WAS PEELING OFF HIS STOMACH. HE WAS PRESCRIBED PERCOCET (ACETAMINOPHEN AND OXYCODONE), GIVEN IBUPROFEN, AND REFERRED TO A WOUND CARE CLINIC. HE ANTICIPATED VISITING THE WOUND CARE CLINIC ON (B)(6) 2025 FOR SKIN REMOVAL AND WOUND HEALING. AT THE TIME OF THE REPORT THE SYMPTOMS WERE ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2531939 | KT RECOVERY + ICE HEAT MASSAGE BALL | HOT AND COLD THERAPY PACK | IME | KT HEALTH, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Required Intervention |