DUODOPA_DUOPA
Received Jul 31, 2026 · Event occurred Jul 1, 2026
Report 3010757606-2026-00255 · MDR key 50107290
Device
Generic name
Tubes, Gastrointestinal (and Accessories)
Manufacturer
Abbvie - Medical Device CenterCatalog number
062941
Lot number
32235109
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 Germany underwent a procedure for the placement of Percutaneous Endoscopic Gastrostomy (PEG) tube. It was reported that the patient experienced a buried bumper. The device remains implanted.
Additional Manufacturer Narrative
H6 Code of E2402 was chosen to capture the event of buried bumper syndrome.Catalog number in D4 is the international List number which is similar to US List Number of 062910.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.