Investigation - evaluation: multiple attempts have been made to request additional information regarding the event.No more information was received.A review of complaint history, device history record, instructions for use (ifu), specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.Review of the device history record of the finished product shows one nonconforming event for "work order, incorrect, incomplete, or missing information".There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
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