On (b)(6) 2015, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On unknown dates, the patient experienced syncope and was hospitalized for further testing.On an unknown date, the patient had a gastroscopy, and a duodenal ulcer was discovered.The patient was discharged from the hospital with unspecified treatments on an unknown date.
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Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The disposition of the device involved in the event was unknown; therefore, a return sample evaluation is unable to be performed.Gastro-intestinal ulcer is a known complication of a peg tube/j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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