It was reported that a large part of the silicone glue is attached to the protective plastic, preventing its correct use in a patient since it does not have enough glue to adhere to the skin.This problem was found by the sales rep upon arrival of the product to the customer, so no patient was involved.
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H3, h6: the device, intended for use in treatment, was not returned for evaluation.A photo and all other provided information has been reviewed establishing a relationship between the device and the reported event.The photo confirms confirmed silicone remained on the carrier.The root cause is a raw material issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with furthers action being taken relating to the failure reported.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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