It was reported that in a allevyn gentle border 15cm x 15cm ctn 10, silicone is offsetting to the back cover leaving the foam pad without silicone in a large area.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10.H3, h6: we have now concluded our investigation for the complaint received.A review of the associated batch manufacturing record 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, there have been further complaints reported with this failure mode in the past three years.The devices were intended for use in treatment.The device was not returned for evaluation.It was reported there is silicone offsetting issue with the dressings.The wound contact surface of the allevyn gentle border 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.We have not been able to confirm a relationship between the event and the product or identify a definitive root cause.No further actions by smith + nephew 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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