(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent umbilical hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2018 during which the surgeon noted there were small pieces of the posterior mesh that started to dissolved, but were still present.These were all removed.There was a murky brown fluid posterior to the mesh, which was irrigated out.There was an area of omentum that was stuck to the mesh, that was resected using electrocautery.Adhesions were taken down using sharp dissection.It was reported that the patient experienced severe pain, mesh infection, dense adhesions, nausea, inflammation, bulging, stress and anxiety.Other procedure was captured in a separate file.No additional information was provided.
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