[94282702]
This spontaneous case was reported by a consumer and describes the occurrence of device material issue ("device getting hot on one side and smoking, and charred the black pad and the gel pad") in a female patient who received aleve tens device direct therapy unit for back pain. On an unknown date, the patient started aleve tens device direct therapy unit. On an unknown date, the patient experienced device material issue. The reporter commented: i just contacted customer service do to my device getting hot and smoking, luckily i was not burnt. The device just got hot on one side and charred the black pad and the gel pad. I have had this for 3 months without any problems most recent follow-up information incorporated above includes: on 29-nov-2017: upon internal quality review, the reported events were revised to device getting hot on one side and smoking, and charred the black pad and the gel pad. Moreover, case category was updated to incident as there was a potential for harm to the patient if device was attached to the skin. This spontaneous report refers to a female patient who used aleve tens device direct therapy unit (transcutaneous electrical nerve stimulation (tens therapy)) for severe back pain on unspecified dates. Within 3 months of use without any problem, device got hot on one side and smoking, and charred the black pad and the gel pad. Patient was not burnt. The event was considered non-serious and is listed according aleve tens device direct therapy unit. At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury. However there was a potential for harm to the patient if the device issue happened while it was attached to the skin. Further information was requested. This case was regarded as incident.
Patient Sequence No: 1, Text Type: D, B5