Description of Event or Problem · 0
THE MEDWATCH REPORT MW5154710 DESCRIBES A CONSUMER'S ISSUES WITH THE FLEXTONE FLEXABS ELECTRICAL MUSCLE STIMULATION (EMS) DEVICE, WHICH WAS PURCHASED ON AMAZON.COM AND HAD BEEN CLEARED BY THE FDA. THE USER EXPERIENCED SEVERAL ELECTRICAL IRREGULARITIES ACROSS THREE SEPARATE UNITS, INCLUDING INCONSISTENT STIMULATION, INTERMITTENT PAINFUL SURGES, A POWER-ON ISSUE, AND DISCREPANCIES IN CHARGING TIMES COMPARED TO THE DEVICE'S MANUAL. ADDITIONALLY, THE DEVICE SOMETIMES POWERED ON BY ITSELF, AND STIMULATION STRENGTH WOULD DIMINISH DURING USE. THE USER ALSO REPORTED EXPERIENCING WELTS WHEN USING THE DEVICE ON THE THIGHS, ALTHOUGH ADJUSTMENTS WITH LEGGINGS MITIGATED THIS PROBLEM. DESPITE FINDING NO SIMILAR CUSTOMER COMPLAINTS IN VERIFIED REVIEWS, NO RECALLS OR SAFETY ALERTS ON AMAZON OR FDA.GOV, AND NO RECORDS OF FLEXTONE IN PUBLIC LITIGATION DATABASES OR ON SAFERPRODUCTS.GOV, THE USER BELIEVES THESE ELECTRICAL IRREGULARITIES SHOULD HAVE BEEN KNOWN, CONSIDERING THE DEVICE WAS CLEARED BY THE FDA. THE USER IS QUESTIONING THE FDA'S CLEARANCE PROCESS, SUGGESTING THAT MORE RIGOROUS REQUIREMENTS FOR RELIABLE FUNCTIONALITY SHOULD BE IN PLACE FOR EMS DEVICES. THE USER HAS REQUESTED THAT THE FDA INVESTIGATE THESE ISSUES AND IMPROVE REGULATION OF SUCH DEVICES TO ENSURE RELIABILITY AND SAFETY. MULTIPLE RELATED REPORTS ARE REFERENCED (MW5154710, MW5154710-1, MW5157622, MW5157623).