The device history record (dhr) was reviewed and indicated that no abnormal process conditions were present during the manufacturing of the product that could have led to the issue reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process, no deviations or non-conformances were documented.One sample was received for the investigation.The sample arrived in an opened pouch.It was visually inspected and there were no abnormalities identified.The electrode was then subjected to residual monomer testing to ensure that the gel is properly cured.The result for the testing performed on the single electrode was well below the maximum limit.This product family has been tested according to iso 10993 guidelines for biocompatibility and found both the hydrogel and skin contacting foam adhesive to be non-cytotoxic, non-irritating, and non-sensitizing.There have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients.Based on all available information, a corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures and no trends have been identified.The details of this event will be recorded for tracking and trending purposes.
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