NEW IMAGE
Received Jul 10, 2026 · Event occurred Jul 6, 2026
Report 1119193-2026-00049 · MDR key 25780708
Device
Generic name
2-piece Ostomy Skin Barrier, Ceraplus, Soft Convex
Manufacturer
Hollister IncorporatedModel number
15704Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Male
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER NOT PROVIDED. IT WAS NOT KNOWN IF THERE WAS ANY DEVICE ISSUES. THE ROOT CAUSE OF THE REPORTED PERISTOMAL WOUNDS COULD NOT BE DETERMINED. ONLY THE DI INFORMATION OF THE UDI IS KNOW DUE TO LACK OF LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO GOT HIS STOMA 9 YEARS AGO HAS BEEN EXPERIENCING PERIODIC PERISTOMAL WOUNDS FOR THE PAST 5 TO 8 YEARS. IT WAS REPORTED HE WAS PRESCRIBED NYSTATIN TRIAMCINOLONE CREAM FOR THE AFFECTED AREA AT THAT TIME AND GETS IT REFILLED AS NEEDED. IT WAS REPORTED THAT HE EXPERIENCED PERISTOMAL SORES WITH THE CURRENT SUPPLY OF THE HOLLISTER NEW IMAGE BARRIERS AND USED THE CREAM. IN ADDITION, IT WAS REPORTED THAT THIS WAS NOT SPECIFIC TO A CERTAIN LOT OF PRODUCTION AND HE HAS SINCE SWITCHED TO A DIFFERENT HOLLISTER OSTOMY BARRIER SKU AND HIS SKIN HAS IMPROVED.