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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H3, h6: the device was not returned for evaluation.All supplied information has been reviewed and we have not been able to confirm the complaint.A documentation review has been conducted, confirming previous complaints of this nature, with corrective actions assigned, which established and inadequate standard operating procedure as the root cause.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Without a valid lot, serial number we cannot perform any additional investigations, but we will continue to monitor for adverse trends relating to this product range.Smith & nephew continue to control the release of batches/devices against manufacturing specifications as part of our approved quality management system.This investigation is now complete, with no additional corrective actions deemed necessary.G1, h6, h10.
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