We have now concluded our investigation into this complaint.The batch record was 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 the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.No complaint sample was available for assessment.A review of the test results for waterproofness for opsite post-op products manufactured in the past three years and no failure result was found.The above investigation did not find any product defect or manufacturing process issue and there was no complaint sample available for assessment.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.Once a sample is received, we will assess and make further investigation.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.
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