ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
|
Back to Search Results |
|
Catalog Number 062910 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Skin Infection (4544)
|
Event Date 03/01/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Reference number (b)(4).Catalog number in d4 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.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 in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
On (b)(6) 2023, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2024, the patient experienced an abscess in the stoma area.The patient was prescribed mupirocin 1-0-1 and amoxicillin/clav every eight hours.On (b)(6) 2024, the abscess had resolved and only a small granuloma remained, which was treated with diprogenta 1-0-1.
|
|
Search Alerts/Recalls
|
|
|