It was reported that, during set up for wound treatment, when the carrier was removed, much of the silicone adhesive of an opsite flexifix gentle 5cmx5m was removed with the carrier and did not remain on the film, so it could not be used.Treatment was resumed, with a back-up device.Patient was not harmed as consequence of this problem.
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Section 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 corrective actions deemed necessary.
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