H3, h6: 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 damage in transit or a potential missed quality check.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found no further instances of the reported event in the past years.This investigation is now complete with no further action deemed necessary.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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