The reported event of "electrodes causing irritation to the scalp" is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A 2 year lot history review could not be conducted as a lot number was not provided.A dhr review could not be performed as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame 11,218,560 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0000004.Per the instructions for use, the user is advised the following: careless removal of the electrodes may cause damage to the skin.Should the electrodes be difficult to remove, use water to dissolve the adhesive.This issue will continue to be monitored through the complaint system to assure patient safety.
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