Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to 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) 2022 , a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2022, the patient was hospitalized with peritonitis.The patient underwent surgery and was very ill.The duodopa infusion continued during the hospitalization.
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