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.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Gastric ulcer is a known complication of a peg-j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On an unknown date, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, a report was received that the patient had ulcerations in the stomach lining, and the j-tube had embedded itself into the stomach lining.It was unknown if the patient received any treatment or if the tubing was removed.No further information was available.
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