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 the adverse event which occurred on (b)(6) 2019.(b)(4) submitted for the adverse event which occurred on (b)(6) 2020.(b)(4) submitted for the adverse event which occurred on (b)(6) 2020.(b)(4) submitted for the adverse event which occurred on (b)(6) 2021.
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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) 2019 during which the surgeon noted ¿it had pulled away resulting in a recurrent hernia that was repaired without mesh.He further noted a partial small bowel obstruction caused by adhesions.¿ it was reported that the patient underwent revision surgery on (b)(6) 2020.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020 and mesh was implanted.It was reported that the patent underwent removal surgery on (b)(6) 2021 during which the surgeon noted ¿the bowel tightly adherent to the mesh and removed both prior implants.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and loss of appetite.The other procedure is captured in a separate file.No additional information was provided.
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