It was reported that when the carrier of the pico 7 dressing was removed, much of the silicone adhesive did not remain on the dressing and removed with the carrier from the dressing, so it could not be used for treatment.A backup was available.No delay was reported.The sample will be returned for investigation.
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H3, h6: the device, intended for use in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes include storage temperature, product failure or raw material issue.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 found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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