H3, h6: the device, intended for use, in treatment was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.This investigation has not been able to determine a definitive root cause, however factors that can contribute to the reported issues are temperature fluctuation during transport and storage.If the material is subject to temperature fluctuations then this can affect the use.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 events.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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Section: h3, h6: the device, used in treatment, has not been returned for evaluation.The information provided has been reviewed and we cannot confirm a relationship between the device and the reported event.No lot/serial number has been provided, therefore a review of device history is not possible.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.A complaint history review was performed for the product and event description, there have been further instances of this nature.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.H6: health effect, medical device problem, investigation findings and investigation conclusion.
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