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.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, the patient experienced abdominal pain and liquid in the peritoneum.On (b)(6) 2019, an exploratory laparotomy was performed, and it was discovered that during the peg-j placement, the round ligament of the liver was damaged.This caused an incorrect placement of the peg tube, allowing gastric fluid to leak into the peritoneum.The patient was subsequently hospitalized.On an unknown date, the j-tube was endoscopically removed.The peg tube was left in place.The j-tube replacement was postponed.No further information was received.
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