FDA Adverse Event
Malfunction
Summary report: N
KT RECOVERY + ICE HEAT MASSAGE BALL
MDR report key: 22964069
·
Received September 4, 2025
Report
- Report Number
- 3007282994-2025-00001
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Report Date
- September 3, 2025
- Manufacturer
- KT HEALTH, LLC
- Product Code
- IME
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
ON (B)(6) 2025, A SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL REGARDING A CONSUMER OF UNSPECIFIED AGE AND GENDER WHO USED A KT HEALTH KT RECOVERY + ICE HEAT MASSAGE BALL. ON AN UNSPECIFIED DATE THE CONSUMER USED A KT HEALTH KT RECOVERY + ICE HEAT MASSAGE BALL. THEY REPORTED THAT THE PELLETS INSIDE THE BALL SHATTERED CAUSING SHARDS TO COME OUT OF THE DEVICE "ALMOST BLINDING" THEM. NO FURTHER CLINICAL DETAILS WERE PROVIDED. FOLLOW UP ATTEMPTS WERE ATTEMPTED BUT NOT SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2081127 | KT RECOVERY + ICE HEAT MASSAGE BALL | HOT AND COLD THERAPY PACK | IME | KT HEALTH, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |