Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, quality control, and photo inspection was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.Photos of the product were provided by the customer and confirmed the presence of foreign matter in the sealed packaging.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events.In addition, there were no other reported complaints for this lot number.Based on the information provided, examination of the photos, and the results of our investigation; the root cause has been determined to be related to manufacturing.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
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