We have now concluded our investigation into this complaint.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 issues recorded in the batch log of the manufacturing records during the manufacturing process that could have caused or contributed to the issue.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device was intended for use in treatment.The returned samples were functionally evaluated which confirmed the failure mode of delamination.No creasing was observed.Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process.During the manufacturing of the dressing, in process checks are undertaken for this product.All material is manufactured according to the specification and only product meeting the release criteria will be passed on for further processing.Unfortunately on this rare occasion in process checks failed to identify the failure mode and therefore the root cause was a manufacturing process issue.We were able to confirm a relationship between the event and the device.As this is a very low occurring issue, no further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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