It was reporter that, ten (10) profore kit ankle 18-25cm usa case 8 seems to be sticking to itself and looping causing it to be very difficult to impossible to get a accurate compression.As this happened in a non-surgical environment, there was not patient involvement.
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H3, h6: the device was not returned for evaluation, images have been provided confirming the reported event.Evaluation of the supplied images confirms the reported event, the images clearly show the coband layer sticking together, which would cause difficulty in application ¿a documentation review has been conducted, confirming previous complaints of this nature, with corrective actions assigned, which established and inadequate standard operating procedure as the root cause.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete, with no additional corrective actions deemed necessary.
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