Reference record (b)(4).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.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.Gastro intestinal perforation 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.
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On (b)(6) 2023, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.It was reported that the tubing placement was unsuccessful due to the doctor being unable to pass the tube through the opening in the stomach, and the patient received staples in the stomach opening.On (b)(6) 2023, the patient was hospitalized due to air in the abdomen found on a ct scan.It was reported that the patient experienced a perforation during the attempted tubing placement on (b)(6) 2023.The patient underwent surgery to fix the perforation.It was reported that new pegj tubing was placed.
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