Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The device involved in the event remained 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- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2022, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2024, the patient experienced pain and an infection in his stoma.On an unreported date, he had a hospital scan of the chest and abdomen and everything was fine, including the tubes.He was prescribed two unknown antibiotics.The symptoms resolved six weeks ago when he finished the antibiotics.The stoma was in good condition.
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