(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.Aspiration pneumonia 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) 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, it was reported that the patient experienced an unspecified acute abdominal event.On (b)(6) 2019, it was reported that the patient experienced increased inflammatory values and aspiration pneumonia.On (b)(6) 2019, the patient was intubated and treated with pirenzepin and intravenous antibiotic(s).At the time of report, the patient continued to receive intensive care, underwent a tracheotomy, and was partially ventilated.
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