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Description of Event or Problem

COMPLAINANT HAD AN ENDERMOLOGY TREATMENT WITH A DEVICE AT A SPA TO REMOVE CELLULITE ON THIGHS. COMPLAINANT SAID THEY HAD SEEN SEVERAL SITES ON THE INTERNET ADVERTISING THIS DEVICE, STATING IT WAS FDA APPROVED, AND THE PROCEDURE WAS PAIN-FREE AND EVEN A PLEASANT EXPERIENCE. COMPLAINANT SAID THE EMPLOYEES IN THIS SPA WERE SUPPOSEDLY TRAINED. COMPLAINANT SAID THE PROCEDURE WAS VERY PAINFUL. COMPLAINANT SAID THERE WERE 3 PROCESSES WITH THE DEVICE, A VIBRATION, A PROCESS WHICH PINCHES THE SKIN AND THEN A SUCTION. COMPLAINANT SAID THE LAST 2 PROCEDURES WERE ESPECIALLY PAINFUL. COMPLAINANT CONTACTED A CLINIC WHO PERFORMS THE PROCEDURE, AND WAS TOLD THAT IF THE PROCEDURE WAS PAINFUL IT WAS BEING DONE INCORRECTLY. THE COMPLAINANT SAID THIGHS ARE BADLY BRUISED FROM THE PROCEDURE. COMPLAINANT SAID WORKS OUT AT A GYM AND KNOWS AN RN WHO GOES THERE. THE RN SAW THEIR LEGS, AND SAID THAT COMPLAINANT APPEARED TO BE JUST A STEP AWAY FROM HAVING A BLOOD CLOT. SHE SAID THAT OTHERS HAVE ALSO COMPLAINED OF PAIN FROM THE PROCEDURE. PLASTIC SURGERY BRANCH OF CDRH SAID THAT FDA HAS NOT CLEARED ANY DEVICES FOR THE CLAIMS MADE FOR THIS PRODUCT.