H3, h6: the device, used in treatment, was not returned for evaluation.However, a control sample and photos have been supplied.The returned sample was examined and confirms the silicone remained on the carrier establishing a relationship between the event reported and the device.Medical/clinical investigation concluded: the retained silicone residue noted on the photo was successfully removed and the issue was reported as resolved with the use of an alternative product.Additionally, there was a delay of less than 30 minutes.Since no further harm has been alleged to this patient no further clinical/medical, assessment is warranted at this time.Should any additional medical information be provided this complaint would be re-assessed.A risk management review has taken place in relation to this complaint, the risk file quote, out of specification raw materials leading to increased adherence causing, pain, wound deterioration and mechanical dermatoses.However, there was no indication to suggest the material was out of spec.A review of the instructions for use contains adequate guidance on the use of the device, including frequency of change, highlighting that this is dependent upon clinical assessment and local protocols should also be taken into consideration.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported event has been reviewed revealing only this instance.The wound contact surface of allevyn life is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.We have been unable to determine a root cause on this occasion.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.
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