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Catalog Number 062918 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Gastritis (1874)
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Event Date 12/15/2022 |
Event Type
Injury
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Event Description
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On an unknown date, a patient in (country) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, the patient was hospitalized for gastritis in the spatial proximity of the intestinal tube.It was reported that the patient was treated with unknown antibiotics, the pegj tubing was removed, and the stoma site was closed.On an unknown date, the patient received a new j tube placement.
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Manufacturer Narrative
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Reference record (b)(4).The device involved in the event was removed from the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Catalog number is the similar us list number, the international list number is unknown.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.Gastritis 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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Search Alerts/Recalls
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