The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue.The device history record shows the product was released per specifications.The root cause of the customer's complaint could not be established as a sample was not returned.Without a sample, it is not possible to isolate the root cause.Potential root cause could be related to a manufacturing related issue; however, this cannot be confirmed with the information available.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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