The device intended for use in treatment, was not returned for evaluation.Therefore, we are not been able to establish a relationship between the reported event or determine a root cause.However, the retain samples were pulled and found satisfactory.A review of the manufacturing records found, that there was no evidence that the product didn¿t meet specifications at the time of manufacture.The probable root cause can be operator, fail to identify the wet pouches after the rectification of the downtime.A complaint history review found other related failures.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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