(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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It was reported that the patient underwent a knee procedure on unknown date and topical skin adhesive was used.The patient was prepped prior to incision with chloraprep and, in addition, the surgeon used tranexamic acid prior to wound layer closure to help mitigate bleeding.Prior to topical skin adhesive application, wound was cleaned with normal saline and then dried.During the procedure, the incision was dry and not oozing blood.It was also reported that after topical skin adhesive was applied, there was some oozing in one location.This was controlled with compression, the location was dried, additional liquid was applied and oozing stopped.Two days post-operatively, the patient experienced bleeding and oozing.The oozing, the patient was experiencing post op, appeared to be coming from the same location.The surgeon opines that topical skin adhesive should provide a tight seal, not allowing fluid to escape.Additional information has been requested.
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