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 (b)(6) 2018, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j).On (b)(6) 2020, a nurse reported that the patient was hospitalized for a dose adjustment and to replace the tubes.A stoma site infection was found with purulent exudate and a culture was done.The patient received unspecified treatment and the tubes were not replaced since they were still functioning.
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