Description of Event or Problem · 0
I RECEIVED CONFIRMATION MAY 31, 2024 FROM THE MEDICAL DEVICE REPORTING TEAM ASSISTANT DIRECTOR MEDICAL DEVICE REPORT MW5154710 I SUBMITTED TO MEDWATCH WAS RECEIVED. THE REPORT EXPLAINS PROBLEMS I HAD CHARGING FLEXTONE FLEXABS ELECTRICAL MUSCLE STIMULATION DEVICE CLEARED BY THE FDA. I SEARCHED FDA.GOV TO DETERMINE REQUIREMENTS USED TO CLEAR THE DEVICE, BUT I FOUND NONE. BECAUSE I PURCHASED FLEXABS ON AMAZON.COM, I READ VERIFIED CUSTOMER REVIEWS FOR FLEXABS, BUT FOUND NO REPORTS OF THE KIND OF PROBLEMS I FOUND. WHEN AN AMAZON CUSTOMER LOGS INTO AN ACCOUNT, A SCREEN DISPLAYS WHAT YOU CAN DO. THERE IS AN OPTION CALLED RECALLS AND PRODUCT SAFETY ALERTS. I CHECKED STATUS AS I WRITE, AND FIND NO ALERTS OR RECALLS FOR FLEXABS OR ANY OTHER PRODUCT. I TRIED TO SEARCH THE BETTER BUSINESS BUREAUS FOR FLEXTONE THE MAKER OF THE FLEXABS, BUT FOUND NO LISTING. I FOUND AN ADDRESS FOR FLEXTONE 2920 2ND AVENUE SE NAPLES, FLORIDA, 34117 FOR A FLORIDA LIMITED LIABILITY CORP, BUT I HAVE YET TO CONFIRM IF THE COMPANY IS THE MAKER OF FLEXABS OR SOMEONE ELSE. I LOOKED IN JUSTIA WHICH IS A FREE INTERNET SITE SERVICE TO SEARCH FOR PUBLIC LITIGATION RECORDS THEN SAFERPRODUCTS.GOV, BUT I FOUND NO RECORD OF FLEXTONE. I HAVE SAID THAT TO SAY CONSIDERING FLAXABS WAS CLEARED BY THE FDA, I WOULD EXPECT THE IRREGULARITIES I AM REPORTING WOULD BE KNOWN. IT IS OVERBURDENING TO OBTAIN THE NEEDED INFORMATION TIMELY. SINCE SUBMITTING MY ORIGINAL REPORT, I USED THE DEVICE TO DETERMINE WHAT IS HAPPENING. I HAVE PURCHASED 3 OF THESE UNITS AND HAVE FOUND ELECTRICAL IRREGULARITIES IN EACH UNIT. I DID READ THE INSTRUCTION MANUAL AND WAS CAREFUL TO AVOID APPLYING LOTION INCLUDING TENSXTENDS GEL. IN USING THE UNITS, I IDENTIFIED THE DEVICE POWERS ON THEN ONE PRESS OF THE PLUS KEY UNTIL EXERCISE STRENGTH STIMULATION IS FELT. THE FIRST SESSION EXERCISE STRENGTH STIMULATION OCCURS AT 27 PRESSES. SESSIONS THERE AFTER REQUIRE AS MANY AS 60 PRESSES FOR EXERCISE STRENGTH STIMULATION, WITH ADDITIONAL PRESSES SHOWING NO EFFECT. BETWEEN 20 AND 22 MINUTES INTO THE SESSION, EXERCISE STRENGTH STIMULATION DIMINISHES UNTIL NEARLY UNOBSERVABLE WHETHER ON STOMACH, THIGH, OR TWAT. THE SESSION SHOULD END WITH TWO SHORT BEEPS TO ALERT THE 25 MINUTE INTERVAL HAS FINISHED. IT HAPPENS SPORADICALLY. THE FIRST TWO UNITS HAD INTERMITTENT ELECTRIC SERGES THAT WERE PAINFUL, BUT WERE INFREQUENT. OTHER SERGES WOULD OCCUR WHEN I WOULD SQUAT TO REACH FLOOR LEVEL WHEN USING THE ABS 8 PACK. SO THAT I COULD ELIMINATE BY AVOIDING SQUATTING. OTHER IRREGULARITIES CAUSE, SUCH AS THE DEVICE POWERING ON BY ITSELF WITHOUT USE OF THE MOTOR ON OFF KEY AND FULL MOTOR CHARGE REQUIRING 1 HOUR AS OPPOSED TO 20 MINUTES AS WRITTEN IN THE INSTRUCTION MANUAL SEEMED TO BE AN EFFECT OF ELECTRICAL IRREGULARITIES IN GENERAL. IN THE FIRST UNIT I USED, I GOT WELTS ON MY THIGHS WHERE THE STIMULATOR WAS PLACED. I STOPPED THE USE ON EACH THIGH UNTIL THE BLISTER LIKE WELT FADED THEN REFITTED IT TO EACH UPPER THIGH SECURED WITH LEGGINGS. THAT CAUSED NO MORE WELTS. THE THIRD UNIT WAS DIFFERENT IN THAT IT HAS YET TO PULSE THE PAINFUL SERGES THE EARLIER TWO UNITS CAUSED. I PERSISTED HERE BECAUSE THE PRODUCT OBVIOUSLY GETS RESULTS BEYOND WHAT I COULD ACHIEVE WITH EXERCISE. I HAVE TO WORK TWICE AS HARD FOR THE RESULTS I GOT PREVIOUSLY WITHOUT EMS. RIGHT NOW EMS GETS RESULTS, BUT WHAT KIND OF CLEARANCE IS THE FDA DOING THAT SUCH SUBSTANTIAL ELECTRICAL IRREGULARITIES WERE UNFOUND ? EACH UNIT WAS PURCHASED ON AMAZON.COM ON OR ABOUT APRIL 21, 2024. I ASK THE FDA TO DETERMINE THE CAUSE OF THE IRREGULARITIES AND REGULATE STIMULATION. EMS PRODUCT MAKERS SHOULD THEN HAVE ESTABLISHED VERIFIABLE REQUIREMENTS FOR RELIABLE FUNCTIONALITY. REFERENCE REPORTS MW5154710, MW5154710-1, MW5157622, MW5157623.