(b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Post procedural complications are known complications of a peg- 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) 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 low hemoglobin levels and melena, was hospitalized and had blood transfusion.After several medical checkups, the reason for the bleeding was not detected.
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