NEW IMAGE
Received Aug 14, 2025 · Event occurred Aug 11, 2025
Report 1119193-2025-00029 · MDR key 22803489
Device
Generic name
2-piece Ostomy Skin Barrier, Convex, Flextend
Manufacturer
Hollister IncorporatedModel number
14908Catalog number
14908
Lot number
5A272
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
85 YR · Male
- 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 DEVELOPED A RASH BENEATH THE HOLLISTER NEW IMAGE BARRIER. THE AFFECTED SKIN APPEARED RED AND MAY HAVE INCLUDED BLISTERING. IT WAS REPORTED THAT SORES WERE ALSO PRESENT AROUND THE OUTER EDGE OF THE BARRIER. THESE SORES HAVE PERSISTED FOR APPROXIMATELY 4-5 WEEKS, BEGINNING AS A SINGLE SORE THAT DID NOT RESOLVE. IT WAS FURTHER REPORTED THAT THE AREA SURROUNDING THE STOMA WAS MILDLY AFFECTED, DESCRIBED AS PINKISH IN APPEARANCE. ADDITIONALLY, IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED A TOPICAL CREAM: TRIAMCINOLONE ACETONIDE USP 0.1%.