It was reported that a patient underwent an open incisional hernia repair procedure (b)(6) 2014 and absorbable straps were used to fixate mesh.A few days after the initial surgery, the patient experienced pain in the abdomen and a high temperature.The patient underwent a re-operation for a defect in the colon.The surgeon opined that there was a strap in the colon, but during the procedure the surgeon could not find a clear cause of the problem, no strap was found in the area.The patient underwent an additional surgery, including having a stoma.Currently, the patient is stable and is healing well.Additional information was requested.
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(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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