It was reported that the patient complained of having a skin rash while treating with the spinal pak device at the electrode site.The patient stated that she did not know if the irritation is from the electrodes or the cover patches or both.The patient changes and rotates the electrodes and cover patches daily.She claimed that the skin irritation started about 3 months ago.The patient described the skin as red, itchy, and irritated like a burn.The patient stated that they started taking benadryl.She developed welts and water blisters.The rash spread all over even on her stomach.The first time the patient had a skin irritation, they stated that they used aloe vera leaves from the plant and the skin irritation went away.The second time the patient had a skin irritation they stated the aloe vera did not work and the skin irritation got really bad.The patient stated that she went to the er where a blood test was taken to check for an infection.The patient reported that there were no infections.The patient was given benadryl intravenous vein, and 2 other medications but did not remember the names.The patient stated that they were also given benadryl 25 mg and claritin 10 mg to take by mouth and told to go see a dermatologist.The patient then reported that they went to see their pcp doctor who prescribed betamethasone 0.1% cream.The patient stated that they stopped using the spinal pak about a month and a half ago and the patient's surgeon is aware that the patient had a skin irritation.The patient will be sending a copy of the paperwork from the er visit.The 72r electrodes lot # 200714 made in usa.Cover patches lot # 131204.The patient will wait until her skin is clear before starting the time test with the 63b electrodes.63b electrodes have been sent to the patient and the old product will be returned.No additional patient consequences have been reported.
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