She reported she used the product approximately 3 times a week until a few months ago. The reporter commented: consumer reported start date for device as over the summer. The reporter considered medical device site injury, scar and paraesthesia to be related to aleve tens device direct therapy unit. ![]() On an unknown date, the patient experienced medical device site injury (seriousness criterion medically significant), scar (seriousness criterion medically significant) and paraesthesia (seriousness criterion medically significant).Īleve tens device direct therapy unit was withdrawn.Īt the time of the report, the medical device site injury outcome was unknown and the scar and paraesthesia had not resolved. On an unknown date, the patient started aleve tens device direct therapy unit unk, tiw. The patient's concurrent conditions included degenerative disc disease. ![]() Other product or product use issues identified: device defective "device did not respond to lowering or shutting off / i purchased a defective aleve tens unit" and device use issue "i used aleve tens to treat degenerative disk pain". This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("cause my back to burn"), scar ("did leave burn marks / i have a brown stain on back from burn") and paraesthesia ("i have tingling sensation on skin where the burn mark used") in a (b)(6) female patient who received aleve tens device direct therapy unit for degenerative disc disease.
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