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) 2011.(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 bilateral hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent revision surgery and recurrent hernia repair surgery on (b)(6) 2011 and mesh was implanted during which the surgeon noted it was found to have adhered and failed.It was reported that the patient underwent revision surgery on (b)(6) 2014 during which the surgeon noted it was found to have failed and migrated into the hernia sac.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.
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