H3, h6: it was reported that on literature review ""negative-pressure wound therapy after stoma reversal in colorectal surgery: a randomized controlled trial"", 1 patient had an anastomotic leak requiring reoperation and fecal diversion 26 days after stoma reversal surgery.No further information is available.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.As no lot number was provided it was not possible to carry out a device history review a complaint history review revealed no similar instances in the last 12 months.A risk management review concluded that the sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.A clinical review concluded without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause 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 root cause is that the dressing has not been applied correctly or dressing not changed frequently enough and in accordance with the ifu.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct dressing application technique and frequency of dressing changes.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products internal complaint reference number: (b)(4).
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