The device, used in treatment, was returned for evaluation.A visual inspection reported silicone remained on the carrier.The functional evaluation confirmed reduced adherence, establishing a relationship between the device and the reported event.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.The manufacturing records show no evidence that the product did not meet specification 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 treatment, when the carrier of two opsite flexifix gentle 2.5cmx5m were removed, much of the silicone adhesive removed with the carrier and did not remain on the film.The treatment was completed with a competitor¿s tape (unknown product).It is unknown if there was a delay.No injury was reported.The samples will be returned for investigation.
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