[118099749]
This spontaneous case was reported by a consumer and describes the occurrence of application site erosion ("top layer of skin is missing on my back") and application site burn ("it burned my back") in a (b)(6) female patient who received aleve tens device direct therapy unit (batch no. 625302) for low back pain. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device stimulation issue "the device shocked me/ output surged so strongly" (seriousness criterion medically significant) on (b)(6) 2018, contraindicated device used "used aleve tens with history of metal knee replacement" and medical device monitoring error "used aleve tens with history of metal knee replacement". The patient's past medical history included knee arthroplasty in 2015. Concurrent conditions included spinal column stenosis and arthritis. Concomitant products included acetylsalicylic acid (aspirin) and paracetamol (tylenol) for pain. On an unknown date, the patient started aleve tens device direct therapy unit. On the same day, the patient experienced application site erosion (seriousness criterion medically significant), application site burn (seriousness criterion medically significant), application site dryness ("my skin is really dry now"), application site pain ("it hurts to touch my skin") and application site exfoliation ("my skin is peeling/ my skin is flaking off"). The patient was treated with cortisone. At the time of the report, the application site erosion, application site burn, application site dryness, application site pain and application site exfoliation was resolving. The reporter considered application site burn, application site dryness, application site erosion, application site exfoliation and application site pain to be related to aleve tens device direct therapy unit. The reporter commented: patient said that output was surging from the entire device and it surged so strongly. Patient reported that she couldn't see her back but had her friend look and that was how she knew it was burnt. She had a knee replacement but she did not believe the metal knee replacement would have caused this problem but was not sure. She did not seek medical attention. Patient said that she felt an actual shock, it felt like she put her finger in a light socket patient did not read the user manual. She used the aleve gel pads (new out of box) and it fully covered the black electrode area. She did not use any lubricant or foreign substances on gel pads or her back. Original batteries were used and there was not damage to the device. It was not her first time using the device (she did not know how many prior number of uses she had), and said she had similar issue during previous use. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27. 9 kg/sqm. The serious events in this case are unlisted in the reference safety information for aleve tens. Use of aleve tens with a history of metal knee replacement may have hypothetically led to an electrical current overflow. Given the electrical nature of this product, company therefore cannot exclude a possible causality and assesses events as related to aleve tens. This case was regarded as an incident. A ptc investigation is underway, and further information is expected.
Patient Sequence No: 1, Text Type: D, B5