[125096381]
This spontaneous case was reported by a lawyer and describes the occurrence of medical device site burn ("horrible burns/skin got burned at the application site") in a (b)(6)year-old female patient who received aleve tens device direct therapy unit for sciatica. Other product or product use issues identified: device use issue "aleve tens used for sciatica pain" on (b)(6) 2018 and device malfunction "device malfunction". Medical conditions: no concomitant drugs. On an unknown date, the patient started aleve tens device direct therapy unit. On (b)(6) 2018, the patient experienced medical device site burn (seriousness criterion medically significant) with medical device site erythema and medical device site pain. The patient was treated with naproxen sodium (aleve caplet). At the time of the report, the medical device site burn had not resolved. The reporter considered medical device site burn to be related to aleve tens device direct therapy unit. The reporter commented: sciatica pain diagnosed in (b)(6) 2018. It was the first time patient used the aleve tens. Patient carefully read the instructions. Device purchased on (b)(6) 2018 and used on the same day (30 minutes cycle during the night). While she was in the shower in the morning on (b)(6) 2018, she noticed the areas where the gel pad was being sensitive. Later on when she looked at the mirror she noticed that it was red and burned. According to patient no excessive or unusual device output noticed during treatment, no lubricant or foreign substances or cleaning agents used on the gel pad and device was not damaged. Gel pads lot number and expiration date unknown. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20. 7 kg/sqm. Most recent follow-up information incorporated above includes: on(b)(6) 2018: this case became potential legal case and device malfunction was added as event. This (b)(6)-year-old female patient used aleve tens device direct therapy unit for sciatica pain and experienced medical device site burn. The event is unlisted in reference safety information for suspect product. Considering probable temporal relationship, relation of the site of application and the electric nature of this device, company cannot exclude causality of suspect product. This case was regarded as incident.
Patient Sequence No: 1, Text Type: D, B5