(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) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2017.It was reported that mesh was implanted during this procedure.It was reported that the patient underwent removal of the mesh products on (b)(6) 2018.It was reported that the patient underwent additional removal of the mesh products on (b)(6) 2019.It was reported that the patient experienced pain/discomfort, nausea, inflammation, adhesions, adhesions to bowel, bowel obstructions, tangled mesh, surgery to remove mesh, and recurrence.No additional information was provided.
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