NEW IMAGE
Received May 2, 2025 · Event occurred Apr 15, 2025
Report 1119193-2025-00015 · MDR key 21949285
Device
Generic name
2-piece Ostomy Skin Barrier, Flextend
Manufacturer
Hollister IncorporatedModel number
16103Catalog number
16103
Lot number
4F052
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Female
- Erythema
- Skin Inflammation/ Irritation
- Erythema
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THE BARRIER WAS NOT SAVED; THEREFORE, A DEVICE EVALUATION COULD NOT TAKE PLACE. A COMPLAINT HISTORY TREND ANALYSIS WAS CONDUCTED FOR SIMILAR COMPLAINTS AND NO ADVERSE TRENDS OBSERVED. A DEVICE HISTORY RECORDS (DHR) REVIEW WAS CONDUCTED AND THE RECORDS WERE COMPLETE AND ACCURATE. THERE WAS NO REPORT OF PRODUCT MALFUNCTION. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE HOLLISTER NEW IMAGE OSTOMY BARRIER FOR OVER THREE YEARS STARTED EXPERIENCING SKIN INFLAMMATION AND REDNESS UNDER THE BARRIER OVER THE LAST MONTH. IT WAS FURTHER REPORTED THAT THE END USER TRIED STEROID SPRAY (TRIAMCINOLONE SPRAY) WHICH SEEMED TO HELP SOMEWHAT.