It was reported that on literature review "negative-pressure wound therapy after stoma reversal in colorectal surgery: a randomized controlled trial", 17 patients had an unknown postoperative complication classified as clavien-dindo ii, which is a complication that required pharmacological treatment.No further information is available.
|
H3, h6: it was reported that on literature review ""negative-pressure wound therapy after stoma reversal in colorectal surgery: a randomized controlled trial"", 17 patients had an unknown postoperative complication classified as clavien-dindo ii, which is a complication that required pharmacological treatment.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 review of complaint history for similar events is not possible due to insufficient information provided regarding the type of wound complication that occurred.A risk management review concluded that there is insufficient information within the complaint to determine the specific type of complication that occurred and/or to provide a causal link between the events and the product therefore a review of the risk management file in relation to this event cannot be performed and no updates to the risk files are required at this time.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.Without further information it is difficult to determine a probable root cause, however it is possible that the dressing has not been applied correctly or dressing not changed frequently enough or the device not being used 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).
|