(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.Post-procedural complications are 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) 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 was hospitalized for pneumonia.The patient was treated with intravenous (iv) cefotaxime antibiotic.On (b)(6) 2019, it was reported that the patient was still hospitalized and had worsened.The patient was having difficulties eating and drinking and was receiving iv fluids.
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