(b)(4).Catalog number is the international list number which is similar to us list number of 062912.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 (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 an unknown date, the patient experienced blood and pus discharge at the stoma site.The patient was prescribed ceclor 500 mg.Oral antibiotics to treat the stoma for 7 days.
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