It was reported that community nurse has reported that she has now seen 4 separate patients, each with what appears to be foam granules in the base of their wounds.Procedure was completed with a competitor device no harm or injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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 device and the reported event or determine a root cause.A probable root cause may include incorrect method used.No lot/serial number has been provided; therefore a review is not possible.A complaint history review found further instances of the reported event.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 risk management review is not required.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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