DUODOPA_DUOPA
Received Jul 31, 2026 · Event occurred Jul 16, 2026
Report 3010757606-2026-00254 · MDR key 50107288
Device
Generic name
Tubes, Gastrointestinal (and Accessories)
Manufacturer
Abbvie - Medical Device CenterCatalog number
062945
Lot number
32441443
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
On an unknown date, a patient in Turkey underwent a procedure for the placement of Percutaneous Endoscopic Gastrostomy (PEG) tube. It was reported that the patient experienced abdominal swelling and tenderness. The patient was admitted to the hospital on (b)(6) 2026. Abdominal CT scan performed on (b)(6) 2026 diagnosed buried bumper. The device has been explanted and replaced.
Additional Manufacturer Narrative
H6 Code of E2402 was chosen to capture the event of buried bumper syndrome.Catalog number 062941-001 is the international List Number which meets the requirements of the similar product listed in Section D4 which is the US list number. The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed. A buried bumper is a known complication of a PEG tube placement. If any further relevant information is identified or obtained, a supplemental MedWatch will be filed.