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) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and two (2) mesh products were implanted.It was reported 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, (b)(6) 2019, (b)(6) 2020, (b)(6) 2020 and (b)(6) 2020.It was reported that the patient experienced severe and chronic pain and discomfort, inflammation, adhesions, fistula, adhesions to small intestine, abdominal wall reconstruction, bowel obstruction, adhesions to bowel and bowel resection.Other procedure is captured under separate file.No additional information was provided.
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