It was reported that, during treatment, 2 profore lite lf system kit case 8 coban layer of compression system were difficult to unroll towards the end and the remainder of the roll became unusable.Treatment had to be completed with a backup device.Patient was not harmed as consequence of this problem.
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Additional information: h4.H3, h6: the device, used in treatment, has been returned for evaluation.There was no obvious visual issue, however, the functional evaluation confirmed the profore layer 4 was difficult to unwind.A relationship against the reported event has been established.A complaint history review confirmed further instances of this nature.A review of the manufacturing records confirmed the device was released according to specification.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.D4, d9.
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