The device, intended for use in treatment, has been returned for evaluation, visual inspection reported no fault found.The functional evaluation found the silicone adhesive remained on the carrier, establishing a relationship between the device and the reported events.The root cause has been determined as a component failure, the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the ifu.A review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.
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It was reported that, during wound treatment when the carrier was withdrawn, much of the silicone adhesive of an opsite flexifix gentle 5cm x 5m roll removed with the carrier and did not remain on the film.It is unknown how the treatment was done.No delay was reported.Patient was not injured as consequence of this problem.
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