Reference record (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.Stoma site infection 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 an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the stoma had smelly secretions.The patient went to the emergency room (er) on an unknown date, and received intravenous (iv) augmentin antibiotic and the area was cleaned.The patient was discharged from the er with oral moxypen antibiotics.The stoma site subsequently showed improvement, and the patient continued to use daktarin ointment.
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