ARPWAVE

Description of Event or Problem

I ENROLLED IN (B)(6) PROGRAM. HALFWAY THROUGH TREATMENT, THE MACHINE BURNT MY SKIN WHERE THE PADS THAT CONNECT TO THE MACHINE STUCK TO MY BODY. I WAS NEVER INFORMED THERE WAS A POTENTIAL FOR THE MACHINE TO BURN MY SKIN - IN FACT, ALL INFORMATION ABOUT THE MACHINE SAY IT DOES NOT BURN THE SKIN. WHEN I INFORMED THE COMPANY OF WHAT HAPPENED, THEY DID SAY IT HAD HAPPENED BEFORE ALTHOUGH RARELY. I WAS ABLE TO TURN MY MACHINE OFF BEFORE I WAS BURNT SERIOUSLY BUT I FEEL AS THOUGH PEOPLE SHOULD BE WARNED ABOUT THE POTENTIAL SIDE-EFFECTS. DOSE OR AMOUNT: LEVEL 2-6.5, FREQUENCY: DAILY. I USED THE ARPWAVE SYSTEM FROM (B)(6) 2011. I HAD ONLINE APPOINTMENT DAILY WITH A TECHNICIAN OVER SKYPE. I HAD TO SLEEP WITH THE MACHINE EVERY NIGHT. I WAS INSTRUCTED TO USE THE MACHINE ON MYSELF TWICE A DAY WITHOUT THE TECHNICIAN.

Description of Event or Problem

ADD'L INFO RECEIVED FROM RPTR, (B)(6) 2011: I ENROLLED IN THE ARPWAVE AT HOME PROGRAM. HTTP://WWW.ARPWAVE.COM. THEY ACTUALLY LET YOU USE THE MACHINE AT HOME. THE MACHINE WORKS, I BELIEVE AND I'M NOT A TECHNICIAN, BUT BY GENERATING AN ELECTRIC CURRENT AND PASSING IT THROUGH YOUR INJURED AREAS OF THE BODY. YOU USE THIS AT HOME AND HAVE APPOINTMENTS WITH TECHNICIANS VIA SKYPE BUT YOU ARE ALSO INSTRUCTED TO USE IT WITHOUT THE TECHNICIAN. THE PADS THAT CONNECT TO THE MACHINE WORE DOWN BUT BECAUSE IT WASN'T SUPERVISED AND I HAD NO IDEA THE MACHINE ACTUALLY BURNT MY SKIN. YOU ARE SUPPOSED TO HAVE PAIN WITH THIS MACHINE SO I DIDN'T REALIZE AT FIRST THAT IT WAS BURNING MY SKIN UNTIL I COULDN'T TAKE IT ANYMORE. I WAS NEVER WARNED BY ANYONE AT ARPWAVE THAT I COULD BE BURNT. IN FACT, MANY OF THE ONLINE INFO I FOUND SAID THAT WAS THE BENEFIT OF THIS MACHINE OVER OTHERS. WHEN I CONTACTED THEM, THE PEOPLE AT THE OFFICE TOLD ME THEY HAD NEVER HEARD OF IT HAPPENING BEFORE. BUT THE TECHNICIAN WHOM I MET WITH, OVER SKYPE, TOLD ME IT HAD MOST CERTAINLY HAPPENED BEFORE. AFTER THE BURN, THE CABLE ALSO BROKE, RENDERING THE MACHINE UNUSABLE. PURCHASE DATE: (B)(6) 2011. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. I LET THEM KNOW WHAT HAPPENED. I DID NOT BUY BUT LEASED THE MACHINE. I RETURNED AFTER THE INCIDENT. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).