The manufacturer was made aware of an allegation that a user received a burn injury to the chest while using the alice nightone device.Observations of powder coming out of the battery and peeling on the surface of the battery were reported.The patient was reportedly prescribed ointment for the burn and has not required any further intervention.The manufacturer has requested return of the device and all accessories that were in use at the time of the event, and the investigation is on-going.On completion of the manufacturer's investigation, a follow up report will be filed.
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The manufacturer received the device for investigation.The original batteries that were used during the event were not returned with the device.There was no thermal damage noted to the battery compartment or to any internal pca components.Battery leakage was found during testing on the top side of the rf shielding.No overheating was noted.The batteries are not manufactured nor provided to the customer by the manufacturer of this device.Although a burn injury to a patient's chest was reported, the manufacturer concludes the device did not cause or contribute to the event.Based on the information available, the manufacturer also concludes no further action is necessary, but will continue to monitor the complaint system for similar events.
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