On (b)(6) 2023, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient went to the er due to a large infection of the stoma site with redness, hardness and presence of pus.It was reported that the patient was treated with two unknown oral antibiotics for the stoma site infection.On an unknown date, the patient developed an abscess, and was treated with unknown treatment.It was reported that the patient is feeling much better since starting antibiotic therapy.
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Reference record (b)(4).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.Catalog number in d4 is the international list number which is similar to us list number of 062910.Stoma site infection is a known complication of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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