Reference number (b)(4).Catalog number in report is the international list number which is similar to us list number of 062910.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation cannot be performed.Peritonitis is a known complication of a peg tube/ j-tube placement.Per the instructions for use (ifu): to secure the peg tube, the peg tube should be pulled until elastic resistance is felt, keep under tension, secure fixation plate into position using the clip, and remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2023, a patient in germany underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2023, the patient developed severe abdominal pain.On (b)(6) 2023, the patient was taken to surgery for treatment of peritonitis and a gastric perforation.The patient was given rocephin and clont intravenously and spend one night in the icu.
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