Additional information: a4, d4 (expiration date), d8, h4.H6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a root cause.Probable cause include incorrect skin preparation, incorrect dressing application or the patient experienced a reaction to one or more of the components of the dressing.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct skin preparation technique and dressing application.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 review of complaint history did not reveal similar events for this nature with no manufacturing problems observed.A clinical/medical assessment was performed and determined no further actions are required.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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