HOMEDICS SHIATSU+ 4.0 FOOT MASSAGER WITH HEAT

Description of Event or Problem

MY MOTHER, (B)(6), USED THE HOMEDICS SHIATSU+ 4.0 FOOT MASSAGER WITH HEAT AS DIRECTED. SHE HAS DIABETIC NEUROPATHY IN HER FEET, WHICH LIMITS HER ABILITY TO FEEL HEAT OR PAIN. WHILE USING THE DEVICE, THE HEATING ELEMENT CAUSED A SEVERE BURN ON HER FOOT. BECAUSE OF HER NEUROPATHY, SHE DID NOT REALIZE SHE WAS BEING BURNED. THE BURN WORSENED DESPITE ATTEMPTS TO TREAT IT AT HOME. IT BECAME INFECTED AND PROGRESSED TO A SERIOUS MEDICAL CONDITION, EVENTUALLY RESULTING IN HOSPITALIZATION AND THE AMPUTATION OF ONE OF HER TOES. SHE HAD MULTIPLE MEDICAL VISITS, INCLUDING TWO HOSPITAL STAYS. DOCTORS CONFIRMED THE INFECTION STARTED AT THE SITE OF THE BURN CAUSED BY THE MASSAGER. SHE WAS ADMITTED TO THE HOSPITAL (B)(6) FOR BACTERIA IN HER BLOOD. THEY FOUND OUT THE BACTERIA WAS COMING FROM HER TOE WHICH WAS BURNED FROM THE FOOT MASSAGER. THE TOE WAS INFECTED AND HAD TO BE AMPUTATED.