Method: the device history and sterilization records were reviewed.Results: review of the dhr found a nonconformance related to the product.However, the nonconformance was identified as a cosmetic issue, and product integrity and functionality met the final acceptance criteria.The dhr anomaly is not related to the alleged device complaint.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.
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