[119510335]
The skin on my chest, and face appears burned from an orthofix cervicalstim bone growth stimulator medical device, and my eyes are irritated from the device. I used the device from (b)(6) through (b)(6) 2018 usually for four hours per day. For the first several weeks i wore the stimulator over an aspen vista cervical collar. The area under the vista collar started to become red and irritated. I though the skin irritation was from the vista collar and in continued using the orthofix device. I answered two phone calls while wearing the medical device. One call from my cell phone and the other from a portable cordless land line phone. Each time i held the phone, the medical device starting making repeated clicking noises. During the time i used the orthofix device, i played games on my cell phone and held the cell phone closer than 7" to the orthofix device. On (b)(6) 2018, i sought medical advice as my skin on my chest and neck was very red, and my face had slight redness by my lips and on my cheeks. I had a sore in the red area on my chest. It was determined that the irritation was probably from the vista cervical collar. From (b)(6) through (b)(6) i used the orthofix device less frequently, and i bolstered the vista collar up from my skin using small pieces of padding. The skin seemed to slightly improve. On (b)(6) 2018, i used the orthofix device for one hour without the vista collar, and the orthofix device was over a tee shirt. After this hour my skin on my chest, neck and face became severely reddened. The red areas again looked and felt like a sunburn and my eyes were sore. I discontinued using the orthofix device. The orthofix device was presented to me out of its box by a nurse. This nurse explained how to use the device. There were no warnings given to me about the device. On (b)(6) 2018, i looked for instructions in the box and found a booklet. On page 15 of the booklet under the heading of "information regarding electromagnetic compatibility and immunity," it states the following: wireless communications equipment such as home network devices, mobile phones, cordless telephones, and their base systems should be kept at least 0. 198 m (7. 8 in) away from cervicalstim. On (b)(6) 2018, i spoke with (b)(4) from orthofix ((b)(4)). She stated she never heard about the phone issues and asked me what page i found this info on. She expressed her regrets over the situation of my skin and said, she would contact another person to contact me. (b)(4) also stated she would file a report with the fda as all incidents are taken seriously. I have not received any calls at this time from anyone from orthofix. I have taken several pictures of these areas that still are affected, and i do have the device.
Patient Sequence No: 1, Text Type: D, B5