H3, h6: the device, intended to be used in treatment, has been returned and evaluated.Visual inspection did not find a foreign substance.The assessment cannot establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes may include something sticking to the film raw material.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 the listed batch and part number with no manufacturing problems observed.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 concluded that there are no prior escalated actions related to this part number and failure mode.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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