Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.A gastric 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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On (b)(6) 2016, a patient in turkey underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, the patient had an endoscopy which showed a gastric lesion.On (b)(6) 2019, the peg-j tube was replaced, and the patient was treated with antepsin and pan active.
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