The device used in treatment has not been returned for evaluation, with no additional information 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.Medical review concluded, the root cause of the reported infection and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Probable cause is inherent risk of infection from procedure.Indications; for primary and secondary closure of skin wounds.Used in the fixation of skin grafts.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch lot number has been provided rendering a review of the device history not possible.A complaint history review found other related failures.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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