[68963875]
This spontaneous case was reported by a consumer and describes the occurrence of electric shock ("this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him") in a (b)(6) male patient who received aleve tens device direct therapy unit (batch no. T02r6x) for pain. The occurrence of additional non-serious events is detailed below. Medical conditions: consumer stated he does not have metal in him and had no phone or metal on him while using the device. Concomitant products included ibuprofen. On an unknown date, the patient started aleve tens device direct therapy unit unk unk, tid. On (b)(6) 2016, the patient experienced electric shock (seriousness criterion medically significant), medical device site injury ("i have a burn mark where this device was"), medical device site pain ("his hurt really bad. ") and medical device site erythema ("i have a red mark where the device was"). Aleve tens device direct therapy unit was withdrawn. At the time of the report, the electric shock outcome was unknown and the medical device site injury, medical device site pain and medical device site erythema had not resolved. The reporter considered electric shock, medical device site pain and medical device site erythema to be related to aleve tens device direct therapy unit. The reporter provided no causality assessment for medical device site injury with aleve tens device direct therapy unit. Quality-safety evaluation of ptc: batch documentation has been reviewed by bayer quality assurance for all released lots. All deviations and non-conformances have also been reviewed by bayerquality assurance to identify potential product quality concerns. Without a returned sample, no further investigation is possible. This issue will be monitored and trended to potentially identify new failure modes. A ptc investigation cannot be initiated as a batch number or sample was not provided thus resulting in an unconfirmed quality defect. Most recent follow-up information incorporated above includes: on 22-feb-2017: correction: the event this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him was recoded and case was upgraded. Incident category was updated. Company causality comment: this spontaneous case was reported by a consumer and describes the occurrence of electric shock ("this literally shocked me / felt like he was touching a live 110 watt power line when the device was shocking him") in a (b)(6) male patient who received aleve tens device direct therapy unit for pain. This event was considered serious as medically important and unlisted according to aleve tens reference safety information. Consumer stated he does not have metal in him and had no phone or metal on him while using the device. Considering the mechanism of action of device and implied temporal relationship, company does not exclude causality between event and suspect device. Further information will be requested.
Patient Sequence No: 1, Text Type: D, B5