We have now concluded our investigation into this complaint.A device history record review was carried out for the lot number supplied.This confirmed that the product had been manufactured in accordance with defined procedures and specifications.There was no record of any problems or deviations occurring during the manufacturing of this product in relation to the reported issue.A complaint history was carried out for this product but no other complaints of this nature have been reported.Unfortunately, no sample has been provided preventing a more in depth investigation we have not been able to determine a root cause for this complaint, without a sample we are unable to confirm the reported issue or take this investigation any further.If a sample becomes available in the future then this complaint may be reopened.Smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.
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