It was reported that, during a treatment setup, on three (3) profore kit lff case 8 the layer #4, flexible cohesive bandage, becomes increasingly difficult to unroll the further down the roll it gets.Patient experiences increased tugging as product is applied, and product sometimes frays or punches through with holes.Treatment was completed with a backup device.
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H3, h6: the device, used in treatment, has been returned and evaluated, 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.
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