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) 2012.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012 during which the surgeon noted her mesh that was on the superior aspect of the recurrent incision hernia had separated from the left superior portion of the hernia and within the hernia itself.As it was crumpled up, the peritoneal aspect of the mesh was mobilized using harmonic and unruffled from the hernia sac itself.The mesh continue to roll back into the patient¿s hernia sac and explanted the portion of her mesh that continued to roll up into the hernia sac itself.It was reported that the patient underwent removal surgery on (b)(6) 2014.It was reported 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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