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) 2011.(b)(4) submitted for the adverse event which occurred on (b)(6) 2017.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent a revision procedure on (b)(6) 2011 and mesh was implanted during which the surgeon noted he lysed adhesions to the previously placed mesh.It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted dense adhesions to the anterior abdominal wall and an adhesiolysis of greater than 120 minutes was performed.The meshes were infected.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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