Reference record # (b)(4).The device manufacturer and 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.It was unknown if the device involved in the event was discarded or will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.Bezoar and gastro-intestinal ulcer are known complication of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic jejunal tube.On an unknown date, a knot formed at the tip of the tube and residue got entangled.A physician stated that the residue on the tip of the tube might have been pulled in and caused tension and an ulcer.
|