It was reported that seprafilm was used for colorectal cancer surgery (robot assisted inferior rectal resection) and the patient experienced loss of appetite and vomiting.Following surgery, fasting started, and three days later, eating resumed.The next day, fasting was resumed due to vomiting, with eating resuming after three days.Five days later, fasting was started due to vomiting, with the patient resuming diet the next day.It was decided that hospitalization would be extended, and the patient would require follow-up due to loss of appetite and low food intake.Three days later, the patient's food intake was adequate, the outcome was 'recovered', and follow-up terminated.No additional information is available.
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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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