We have now concluded our investigation for the complaint received.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.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The devices were intended for use in treatment.The returned dressings were visually and functionally evaluated which confirmed the issue of silicone offsetting.This confirmed a relationship between the event and the device.The wound contact surface of the 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 possible the silicone adhesive on the wound contact layer has problem, with the root cause established as a raw material issue.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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