The device, intended for use in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes include storage temperature, the ifu offers guidance on this matter, and or a product failure.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.The complaint history review found further instances of the reported event in the past years.The associated risk files contain details relating to harm.However, no harm has been alleged.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.This investigation is now complete with no further action deemed necessary.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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