H10.H3, h6: the device, used in treatment, has not been returned for evaluation, nor any photos to show the alleged issue.We have been unable to establish a relationship between the reported event and the device or determine a root cause on this occasion.If the device is returned in the future, this complaint will be re-assessed.It was noted that treatment was continued using the product, with no further reported issues.As no control sample has been returned we are unable to fully investigate this complaint, therefore we are unable to provide probable causes as to why these events happened, however it is noted historically there has been issue where the bandages has been rolled too tight, presenting difficulty upon use.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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