(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the device sample was not returned.No picture available for review.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available this investigation will be updated with the evaluation results.
|