Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The disposition of the device involved is unknown; therefore, it is unknown if a return sample evaluation can 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 an unknown date, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2023, the patient was hospitalized for medical issues unrelated to abbvie's device.It was noted that the patient's stoma had candiadis diagnosed in (b)(6) 2023 which had not responded to topical treatment.The patient was started on an unknown antibiotic therapy while in the hospital.On (b)(6) 2023, the patient's peg tube was removed and was replaced by a new 20 fr peg tube.
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