The devices, intended for use in treatment, have been received for evaluation.Four unopened dressings were received.The visual and functional evaluation found no faults with the returned devices, the test results met specifications.We have not been able to establish a relationship between the devices and the event reported.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found additional complaints for the product and failure mode reported in the last three years.Potential causes for the event reported include storage location and temperature.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.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.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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