ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Catalog Number 062910 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Aspiration Pneumonitis (4455)
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Event Type
Death
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Event Description
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On an unknown date, 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 date, during the titration phase of duodopa, the patient experienced aspiration pneumonia and subsequently died.The information was received from a slide presentation for a seminar, and the presenting physician declined to provide further information regarding the events.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.
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Manufacturer Narrative
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Reference record (b)(4).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.The disposition of the device involved in the event was unknown; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia 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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