If information is provided in the future, a supplemental report will be issued.(b)(4).Upon receipt at our post market quality assurance laboratory that the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
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