The device used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.Probable root causes include application techniques and or a failed component, the ifu offers further guidance.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device no batch/lot number has been provided, therefore a review of the device history has not been 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.
|