H3, h6: we have now concluded our investigation into the reported 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.A complaint history review, was performed for the product and event description, there have been similar instances reported in the past three years.Event occurred did not occur during patient treatment.The device intended for use in treatment was returned for evaluation and found to be as described in the complaint.This established a relationship between the reported event and the device.Root cause has been traced to a storage issue in that this staining has been know to occur when the dressing is reaching the end of its shelf life and has not been stored in the right conditions.The device must be stored in accordance with the conditions outlined in the ifu users of the device are advised to consult the instructions for use for the product provides to delineate future occurrences of the event.The ifu provides comprehensive instructions of the operation, use and limitations of the device and the conditions in which it must be stored.The investigation has been closed.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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