It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent a surgical procedure on (b)(6) 2017 during which the surgeon noted adhesions between the bowel and the undersurface of the peritoneum and the mesh had penetrated the peritoneum.During dissection, the small bowel was lacerated and resected.It was reported that the patient underwent recurrent incisional hernia repair surgery on (b)(6) 2019.It was reported that the patient underwent recurrent incisional hernia repair surgery on (b)(6) 2021 during which the surgeon noted the colon was so stuck in the recurrent hernia and so densely adherent to the mesh, that he was afraid that he might of entered it causing enterotomy.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
|
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.Mwr (b)(4) submitted for adverse event which occurred on (b)(6) 2017.Mwr (b)(4) submitted for adverse event which occurred on (b)(6) 2019.Mwr (b)(4) submitted for adverse event which occurred on (b)(6) 2021.
|