MalfunctionIME
KT RECOVERY + ICE HEAT MASSAGE BALL
Received Sep 4, 2025
Report 3007282994-2025-00001 · MDR key 22964069
Device
Generic name
Hot And Cold Therapy Pack
Manufacturer
Kt Health, LlcProduct problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- Visual Impairment
- Visual Impairment
Narrative
Description of Event or Problem
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.