We have now concluded our investigation into this complaint.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.The complaint history file does not contain further instances/ related events of the reported event.The device was intended to be used for treatment.The returned samples were functionally evaluated which confirmed the failure mode of the backing paper being difficult to remove from the dressing.This 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.We were able to confirm a relationship between the event and the device.The root cause was determined as a manufacturing process issue.As the occurrence rate is within acceptable range, no further actions by smith and nephew are deemed necessary at this stage.This complaint information will be shared with the relevant manufacturing team.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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