(b)(4).Catalog number, is the international list number which is similar to us list number of 062918.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.Duodenal ulcer 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.
|
On (b)(6) 2018, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019 the patient was hospitalized to determine the cause for weight loss.A gastroscopy was performed, and a duodenal ulcer was found.The ulcer was treated with an unspecified medication.On (b)(6) 2019, the patient was discharged from the hospital.The peg-j tubing remained in place.
|