CERAPLUS BARRIER RING
Received Feb 10, 2026 · Event occurred Jan 23, 2026
Report 1119193-2026-00009 · MDR key 24305613
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR · Male
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED DUE TO LACK OF LOT NUMBER INFORMATION. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION UNDER THE OSTOMY BARRIER RING CANNOT BE DETERMINED. ONLY THE DI INFORMATION OF THE UDI IS KNOWN DUE TO LACK OF LOT NUMBER INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER USING THE HOLLISTER CERAPLUS SLIM FIT BARRIER RING EXPERIENCED IRRITATED SKIN AND THE NURSE HAD TO USE NYSTATIN. IT WAS FURTHER REPORTED THAT THE RING WAS APPLIED AFTER THE OPERATION AND THINKS THEY USED THE RING TWICE AND NO LONGER USING THE PRODUCT.