A patient underwent an internal anal sphincterotomy and ileostomy (laparoscopic or robot-assisted) surgery for rectal cancer in which seprafilm was used.Two days post-operative, no issues were noted, and a liquid diet was started.Four days post-operative, the patient experienced vomiting and fasting was started.Six days following surgery an intestinal obstruction at the stoma site was diagnosed following a ct.The following day, the gastric tube was removed, and an ileus tube was inserted.It was reported 16 days after surgery, the ileus tube was removed, and a liquid diet was started as the abdominal x-ray showed improvement.Eleven days later, the patient was discharged from the hospital.At the time of this report, the patient outcome was not reported.No additional information is available.
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Additional information: h6 and h10.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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