We have now concluded our investigation for the complaint received.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of its finished product specification.There was no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.No complaint sample was available for assessment but a review of our database has found this complaint to be the only complaint received for this issue for this product code and lot number therefore deemed an isolated incident.The database of change controls for the agb product family was reviewed and it was found there were no changes to raw materials, manufacturing methods or equipment since the original qualification exercises that could have contributed to the issue experienced by the customer or alleged adverse reaction.Unfortunately, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.The investigation did not find product defect or manufacturing process issue.The complaint sample was not available at this time.Once the sample received, an assessment may take place to make further investigation.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Will proceed with a medical assessment based on clinical supporting documents provided.If no relevant medical information is provided can close the mi task.Approved by (b)(6), md.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information surgical procedure/post-operative care review device labeling (including technique guides, ifus, etc.).No clinical supporting documents were provided to conduct a thorough assessment of the reported issue.
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