Date sent to the fda: 10/04/2022.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) 2012.
|
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 revision surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2012 during which the surgeon noted dense involvement of the small bowel serosa with the previous meshes.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.
|