NEW IMAGE
Received Aug 19, 2025 · Event occurred Aug 15, 2025
Report 1119193-2025-00030 · MDR key 22840785
Device
Generic name
2-piece Ostomy Skin Barrier, Ceraplus
Manufacturer
Hollister IncorporatedModel number
11203Catalog number
11203
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
89 YR · Female
- Skin Erosion
- Skin Erosion
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 COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. 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. ONLY THE DI OF THE UDI INFORMATION IS AVAILABLE SINCE LOT NUMBER INFORMATION NOT PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE HOLLISTER NEW IMAGE CERAPLUS BARRIER DEVELOPED A WOUND ABOVE THE STOMA UNDER THE BARRIER AND THE AREA NOW NEEDS TO BE PACKED. IT WAS FURTHER REPORTED THAT THE WOUND HAD BEEN THERE FOR 5 WEEKS, AND SHE WENT TO A NURSE PRACTITIONER AT THE WOUND AND OSTOMY CLINIC. ADDITIONALLY, IT WAS REPORTED THAT THEY PRESCRIBED AND ORDERED THE WOUND PACKING SUPPLIES AND THAT THE WOUND IS BEING TENDED TO BY A HOME HEALTH NURSE. HOLLISTER IS SENDING OUT A DIFFERENT OSTOMY PRODUCT FOR HER TO TRIAL.