NUFACE

Description of Event or Problem

I HAD A FACIAL ON TUESDAY (B)(6) 2023 AND THE TECHNICIAN ASKED ABOUT AN ADDITIONAL SERVICE USING THE NUFACE DEVICE. WE PROCEEDED AND I DID FEEL TINGLING AND A BURNING SENSATION AS SHE USED THE DEVICE ON ME. SHE SAID THAT WAS NORMAL. THURSDAY (B)(6) I NOTICED A VISIBLE DEEP INDENTION ON ONE SIDE OF MY FACE FROM THE BASE OF MY NOSE THAT LEADS UP TO MY EYE. I CONTACTED THE PROVIDER AND AWAITING A RESPONSE. I ALSO HAVE CONTACTED NUFACE VIA EMAIL AND ALSO AWAITING A REPLY. I AM TRYING TO FIND THE DATA THAT WAS SUBMITTED TO THE FDA THAT SHOWS ADVERSE EVENTS AND ALERT THE FDA TO THIS CONCERN. ONLINE I HAVE FOUND SOME INSTANCE OF INDENTIONS FROM PEOPLE THAT HAVE USED THE DEVICE AS WELL.