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) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for 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 small bowel resection and extensive lysis of adhesions on (b)(6) 2017.It was reported the patient underwent partial mesh removal on (b)(6) 2017.It was reported that the patient underwent surgical procedures on (b)(6) 2017 and (b)(6) 2017.It was reported that the patient experienced severe pain, adhesions, abscess, severely dilated and ischemic colon, nausea, vomiting, chills, inflammation, scarring, disfigurement, loss of appetite, stress and anxiety.No additional information was provided.
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