It was reported that the profore that was delivered, had a very bad coban wrap, to the point they were tempted to throw it out and use their own old coban.The coban was wrapped with wrinkles and very hard to unravel.5 boxes out of the case were like this.No case involved.
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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 reported event or determine a root cause.This investigation has not been able to determine a definitive root cause, however factors that can contribute to the reported issues are temperature fluctuation during transport and storage.If the material is subject to temperature fluctuations, then this can affect the use.No batch/lot number has been provided, therefore a review of the device history has not been possible a complaint history review found other related events.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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