THE FLASHER 2.0.

Description of Event or Problem

TO WHOM IT MAY CONCERN, I AM WRITING TO FILE A FORMAL COMPLAINT ABOUT NOOD'S THE FLASHER 2.0. I USED THIS PRODUCT TWICE AND ENDED UP WITH AN AWFUL RASH ON MY LEG THAT I NEEDED TO GO TO THE EMERGENCY ROOM FOR. I FOLLOWED THE INSTRUCTIONS AND COMPLETED THE TRAINING MATERIAL PRIOR TO USING THE PRODUCT. USING ON THE SETTING ON 5 (GOES UP TO A POWER SETTING OF 7). I HAVE BEEN TAKING ORAL TABLETS APPLYING THE ANTISEPTIC CREAM FOR 3 WEEKS NOW. IT HAS STILL NOT HEALED AND IS SPREADING ON MY LEG. PICTURED IS WEEK 1 AND 3 OF THE HEALING PROCESS. IN MY OPINION THIS PRODUCT SHOULD NOT BE FDA APPROVED. THE BEST SOLUTION THAT NOOD COULD PROVIDE WAS TO OFFER ME A REFUND AND PROVIDE ME WITH SOME SOOTHING GEL. ON THE CONTRARY, I'M STUCK WITH LARGE MEDICAL BILLS AND A RASH THAT I AM NOT ABLE TO CURE. WHO KNOWS HOW LONG THIS IS GOING TO TAKE TO HEAL. SINCERELY (B)(6).

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER ON 6/7/2023 FOR REPORT #MW5118130. THEY CLAIMED THAT THEIR DERMATOLOGIST SUGGESTED THAT THIS WAS NOT CAUSED BY THEIR PRODUCT AND THAT IT WAS ECZEMA. EVEN THOUGH I HAVE RECEIVED CONFIRMATION BY 2 MEDICAL PROFESSIONALS REGARDING THIS (1 THAT PROVIDES IPL TREATMENT). THE BEST SOLUTION THEY COULD PROVIDE WAS A REFUND AND SOME SOOTHING GEL. I WILL NOT BE TRUSTING ANY OTHER OF THEIR PRODUCTS. WHEN LOOKING AT REVIEWS IT APPEARS AS I'M NOT THE ONLY ONE WITH THIS ISSUE. I HOPE THAT YOU WILL UNDERSTAND THE URGENCY OF THIS MATTER AND TAKE ACTION. I WOULD HATE FOR ANYONE ELSE TO HAVE TO GO THROUGH WHAT I HAVE EXPERIENCED. I HAVE PREVIOUSLY SUBMITTED A MEDWATCH REPORT REGARDING THIS MATTER.