ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Catalog Number 062943 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ulcer (2274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.A bezoar and gastro-intestinal ulcers are known complications of j tube placement.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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Event Description
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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 an unknown dates, the patient experienced the tubing occasionally "introduced" slightly inward.On an unknown date, the patient again experienced the "suction of the tube into the stomach".In (b)(6) 2021, the patient underwent an endoscopic evaluation which revealed a bezoar at the distal tip of the internal tube and a small ulcer was observed at the entrance of the pylorus.The patient was treated with omeprazole 20 mg every 12 hours for 1month and a replacement of the tube was scheduled in one month.
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