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.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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In (b)(6) 2021, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2021, the patient experienced abdominal pain and was admitted to the hospital.On (b)(6) 2021, the patient was discharged from the hospital.On (b)(6) 2021, the patient was admitted to the hospital again in the gastroenterology department for 2 days due to severe pain in the stomach and severe hypertension after the peg-j tube placement.It was reported that the fixation plate was very loose.The gastroenterologist tightened the fixation disk and the patient began unspecified antibiotic therapy.On (b)(6) 2021, the patient was discharged home.An alternative etiology for event of abdominal pain was reported as peg j tube placement.
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