2 PORT CONTROLLER (HL-C2J)
Received Dec 6, 2024 · Event occurred Dec 3, 2024
Report MW5163373 · MDR key 20879614
Device
Patient
NA · Male
- Chest Pain
- Headache
- Dizziness
- Chest Pain
- Headache
- Dizziness
Narrative
Description of Event or Problem
DEAR FDA, ON 11/26/2024 I CONTACTED HEALTHLIGHTLLC AND PURCHASED MEDIUM 132 DIODE LED PAD WITH THE 2PORT USB CONTROLLER. HTTPS://HEALTHLIGHTLLC.COM/WHAT-IS-INFRARED-LIGHT-THERAPY/MEDIUM-132-DIODE-PAD/ FROM (B)(6) ON (B)(6) 2024 I RECEIVED THE LED RED LIGHT PAD AND CONTROLLER AND BOTH MY WIFE AND I USED IT FOR 20 MINUTES AS IT WAS RECOMMENDED. WE BOTH EXPERIENCED SEVERE BODY PAINS, MY WIFE ALSO FELT REALLY DIZZY, BUT I ALSO HAD A SEVERE HEADACHE AND HEART PAIN. THE LED RED LIGHT EMITS EMF RADIATION THAT WAS HARMFUL FOR BOTH OF US. FURTHERMORE, PULSATING FREQUENCY OF THE CONTROLLER EXASPERATED THE PAIN MUCH MORE SEVERELY. BOTH OF THESE UNITS WERE HARMFUL FOR OUR HEALTH AND WE ARE LEFT WITH NO CHOICE, BUT TO RETURN THESE ITEMS TO THEM AND ASKED FOR THE FULL REFUND WHICH THEY REFUSED. NO DEVICE SHOULD BE SOLD TO THE CONSUMER WITHOUT ADEQUATELY TESTED IN THE HUMAN TRIALS. WHEN I HAD EXPRESSED THE PAIN THAT THE LED PAD AND CONTROLLER CAUSED (B)(6) REPLY SIMPLY WAS, NOBODY COMPLAINED BEFORE ABOUT THIS. JUST BECAUSE NOBODY COMPLAINED ABOUT IT, DOES NOT MEAN THE DEVICE IS NOT HARMFUL FOR HEALTH AND USE TO THE CONSUMERS. IF YOU HAVE ANY QUESTIONS, PLEASE FEEL FREE TO REACH OUT TO ME AT (B)(6) THANK YOU (B)(6). REFERENCE REPORT #MW5163372.