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
Obstruction/Occlusion (2422); No Code Available (3191)
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Event Date 01/04/2021 |
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 062910. the device involved in the event was not returned and the device disposition is unknown; 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. intestinal obstruction is a known complication of a 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) 2020, 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 was hospitalized for a suspected ileus.During the procedure, the surgeon determined that the patient experienced small intestine invagination (intussusception).The patient was treated with resection of small intestine, with removal and replacement of peg/peg-j system.
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