inforMED
InjuryKNT

Duopa/Duodopa

Received Jul 31, 2026 · Event occurred Jul 1, 2026

Report 3010757606-2026-00251 · MDR key 50106457

Device

Generic name

Tubes, Gastrointestinal (and Accessories)

Catalog number

062941

Lot number

unknown

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 Israel underwent a procedure for the placement of Percutaneous Endoscopic Gastrostomy (PEG) tube. It was reported that the patient experienced stoma site redness treated by family doctor with unknown oral antibiotic. No cultures were performed. 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.