ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Catalog Number DUODOPA PEG TUBE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Reference record (b)(4).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 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 stoma site infection is a known complication of a peg tube placement.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) 2019, a patient in the usa underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2019, the patient¿s spouse reported that there was skin redness and drainage around the stoma site.A culture revealed unknown bacteria on the skin and the patient was diagnosed with a stoma site infection, which required a 10 day course of cephalexin.On an unknown date, the stoma site infection resolved.
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