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.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2020, a patient in (country) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020, while still hospitalized after the peg-j placement, the patient experienced stoma site pus, pain, and inflammation.The patient was afebrile.On (b)(6) 2020, an x-ray was performed, showing the j-tube had migrated to the stomach.On (b)(6) 2020, abdominal and pelvic computed tomography (ct) scans were performed, with results unknown.On (b)(6)2020, endoscopy was performed to reposition the peg-j tubing.On (b)(6) 2020, the patient started taking amoxicillin + clavulanic acid antibiotic for the stoma infection.The route of the antibiotic was not specified.The stoma infection and inflammation subsequently resolved.
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