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; 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) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.The patient visited the hospital on (b)(6) 2020 to have a surgeon and a gastroenterologist check the stoma site because the stoma area was red, with local pain and a little pus.There was no hospitalization.Doctors prescribed oral antibiotic augmentin for 8 days.On (b)(6) 2020 inspection of the stoma found no redness, but a little pus inside.The patient¿s caregiver was retrained in caring of stoma area and pump use.
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