The patient consulted a clinician and complained that the device electrodes were causing itchy red and swollen skin and hives form head to toe.The physician prescribed prendisone to take orally.The patient did not follow instructions as directed by not rotating the electrodes when changing them.Instead they were placed on the already irritated area.The patient was offered alternative sensitive skin electrodes for monitoring period completion.Per patient user guide sup546, patients are provided warning statements regarding electrode skin irritation.Patients are instructed to contact lifewatch services customer support prior to using the mct 3l monitoring system if they have known allergies to nickel or other metals.The patient is also informed in the user guide that if they develop skin irritation they should contact their healthcare professional.The ifu located on the pouch states the electrodes are hypoallergenic and an electrode is to be worn for less than 72 hours.The electrodes are also pvc and latex free.The electrode supplier has not undergone changes in the production process or raw materials and meet requirements for skin sensitivity / cytotoxicity / irritation.No additional information is known to lifewatch services, inc.At this time.
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