Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.(b)(4).A bezoar and gastro-intestinal ulcer are known complications of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
On (b)(6) 2021, 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) 2021, the patient experienced abdominal pain, nausea, vomiting, and loss of appetite.On (b)(6) 2021, the patient was taken by ambulance to the er (emergency room).On (b)(6) 2021, an intestinal occlusion was excluded, and a gastroscopy was performed.A duodenal ulcer and phytobezoar at the tip of the j-tube were discovered.On (b)(6) 2021, the j-tubing and phytobezoar were removed.A new peg-j tube will be placed once the duodenal ulcer heals.
|