Description of Event or Problem · 0
I AM WRITING TO FORMALLY REPORT A SAFETY ISSUE REGARDING THE TUMAKOU HIGH-FREQUENCY FACIAL MACHINE, SOLD ON AMAZON UNDER ASIN B07YXQW4H1 (PRODUCT LINK). SEVERE BURN INJURY FROM PRODUCT USAGE. AFTER USING THIS PRODUCT AS INSTRUCTED, I EXPERIENCED PAINFUL BURNS ON MY SKIN. I FOLLOWED THE GUIDELINES PROVIDED BY THE MANUFACTURER AND DID NOT EXCEED THE RECOMMENDED USAGE TIME, YET THE DEVICE CAUSED VISIBLE BURNS AND IRRITATION. I HAVE IMAGES OF MY INJURY FOR REFERENCE. FALSE FDA COMPLIANCE CLAIM. UPON REVIEWING THE FDA 510(K) DATABASE, I FOUND THAT THIS PRODUCT DOES NOT HAVE FDA CLEARANCE OR APPROVAL. HOWEVER, THE SELLER MISLEADINGLY IMPLIES FDA COMPLIANCE ON THE PRODUCT LISTING. THIS RAISES SERIOUS CONCERNS REGARDING CONSUMER SAFETY AND REGULATORY VIOLATIONS. REQUEST FOR FDA INVESTIGATION. GIVEN THE POTENTIAL HARM THIS PRODUCT POSES TO CONSUMERS, I URGE THE FDA TO: INVESTIGATE THE MANUFACTURER¿S CLAIMS REGARDING FDA APPROVAL. ASSESS THE PRODUCT¿S SAFETY DUE TO MULTIPLE REPORTS OF BURNS AND INJURIES. TAKE APPROPRIATE ENFORCEMENT ACTIONS IF THE PRODUCT IS FOUND TO BE NON-COMPLIANT WITH FDA REGULATIONS.