It was reported that, when the carrier was removed from opsite flexifix gentle 2.5cmx5m, almost all silicone adhesive removed with the carrier and did not remain on the film.As this happened in a non-therapeutic environment, there was not patient involvement.
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H3, h6: the complained product has been returned, confirming the reported event visual inspection, noted no obvious defects, functional testing confirmed silicone remained on the carrier, reducing adherence.The root cause has been deemed a component failure, 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 previous complaints 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.
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