DUODOPA_DUOPA
Received Jul 31, 2026 · Event occurred Jul 1, 2026
Report 3010757606-2026-00253 · MDR key 50107070
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
- Skin Infection
Narrative
Description of Event or Problem
On an unknown date, a patient in Netherlands underwent a procedure for the placement of Percutaneous Endoscopic Gastrostomy (PEG) tube. It was reported that the patient experienced insertion site redness, pain, and unpleasant smelling with heavy puss producing discharge. The patient was diagnosed with a stoma site infection and treated with an unknown oral antibiotic. The device remains implanted.
Additional Manufacturer Narrative
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. 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.