It was reported that, during set up for wound treatment, when the carrier of a opsite flexifix gentle 5cmx5m was removed, much of the silicone adhesive removed with the carrier and did not remain on the film, so it could not be used.Treatment was performed, with a competitor tape instead.Patient was not harmed as consequence of this problem.
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H3, h6: the device was not returned for evaluation, without a physical sample we cannot confirm the reported event the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the instructions for use.A documentation review has been conducted, confirming the device was released according to specifications, complaint history has recorded previous occurrences of this nature, with corrective action, currently under effectiveness review, the complained product was released prior to the actions being initiated.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no additional corrective actions deemed necessary.
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