(b)(4).
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) 2015.
Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015.
Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015.
Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.
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It was reported by an attorney that the patient underwent ventral hernia repair surgery on (b)(6) 2007 and mesh was implanted.
It was reported that the patient underwent laparoscopic sleeve gastrectomy on (b)(6) 2015 during which the surgeon noted numerous adhesions of omentum to the anterior wall and to the mesh.
He performed extensive lysis of adhesions.
It was reported that the patient underwent laparoscopic enterolysis on (b)(6) 2015 during which the surgeon noted multiple adhesions of the omentum to the anterior abdominal wall and adhesions of a loop of bowel to the upper third of the mesh, creating a kinking effect.
It was noted that a piece of the mesh was stuck to the small bowel.
This piece of mesh was separated from the small bowel and explanted.
It was reported that the patient underwent diagnostic laparoscopy on (b)(6) 2015 during which the surgeon noted that the small bowel was so severely adherent to the mesh and indurated, requiring resection.
The surgeon also noted kinking in the bowel and dense intra-loop adhesions.
He explanted to remaining portion of the mesh.
It was reported that the patient underwent exploratory laparotomy due to closed loop bowel obstruction on (b)(6) 2016 during which the surgeon noted gangrenous small bowel, multiple inter-loop bowel adhesions, multiple abdominal adhesions and thick scarring.
The surgeon performed lysis of adhesions and a small bowel resection.
It was reported that the patient underwent ventral hernia repair surgery on (b)(6) 2016.
It was reported that the patient experienced recurrent small bowel obstructions, gangrenous bowel, fibrosis fat necrosis, foreign body granulomatous reaction to the mesh, fibrosis, scarring, acute chronic inflammation, abdominal pain and discomfort, nausea and vomiting.
No additional information is provided.
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