It was reported that, while using a opsite flexifix gentle2.5cmx5m, when the carrier was removed, much of the silicone adhesive did not remain on the film, so it could not be used.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H3, h6: the device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed reduced adherence.Probable causes include storage temperature, and or raw material issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
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