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 during patient treatment.The device used in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.It was therefore not possible to establish a relationship between the reported event and the device.It was reported that the patient experienced redness, swelling, and itchy sensation which lasted two days.The reaction was treated with medication and the current patient status was reported as ¿normal.¿ since no further harm is anticipated, no further clinical/medical assessment is warranted at this time.It has not been possible to establish the root cause of the issue.Probable root cause is a patient reaction to one or more of the materials in the dressing.Users of the device are advised to consult the instructions for use, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.The user risk assessment for the device provides details of possible sensitisation reactions and irritation or irritants contact dermatitis, as possible harms caused by toxicology of the materials used in the dressing.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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