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.
|
On (b)(6) 2021, a patient in portugal underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2021, the patient experienced stoma site inflammation, redness, and abdominal pain.The stoma was cleaned with chlorhexidine, but the symptoms persisted.On (b)(6) 2021, a stoma swab was taken, and the patient was treated with oral amoxicillin + clavulanic acid antibiotic for the stoma infection for 10 days.
|