Reference record (b)(4).Catalog number is the similar us list number, the international list number is unknown.The lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing the device involved in the event was not returned and remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia 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) 2020, 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) 2020 the patient experienced pyrexia.The patient was treated with intravenous antibiotic therapy, ceftriaxone, for suspected aspiration pneumonia after surgical procedure.On an unknown date, x-ray confirmed extension/dilation of the large intestine.It is suspected that the tube placement is beyond the ligament of treitz.
|