(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) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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It was reported by an attorney that the patient underwent recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent additional surgery on (b)(6) 2019 during which the surgeon noted the prior mesh was protruding.Portions of the protruding mesh and recurrent hernia contents were removed.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted he removed the infected mesh.It was reported that the patient underwent additional surgery on (b)(6) 2020 during which the surgeon noted he found and lysed significant abdominal wall adhesions.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.It was reported that patient had a previous hernia repair surgery on (b)(6) 2010 and mesh was implanted.Other procedure was captured in a separate file.No additional information was provided.
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