(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.Mwr-11122018-0000271428 submitted for adverse event which occurred on (b)(6) 2017.Mwr-11122018-0000271432 submitted for adverse event which occurred on (b)(6) 2018.
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It was reported by an attorney that the patient underwent epigastric ventral hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted that he ¿encountered an obvious draining sinus tract at the site of the mesh with fluid collection.The previously placed mesh is noted to be loose and beneath it was an obvious recurrent hernia sac.¿ it was reported that the patient underwent an additional removal surgery on (b)(6) 2018.It was reported that the patient experienced severe pain, infection, hernia recurrence, nausea, chills, inflammation, loss of appetite, stress and anxiety.No additional information is provided.
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