PREMIER
Received May 29, 2025 · Event occurred May 28, 2025
Report 1119193-2025-00019 · MDR key 22108526
Device
Generic name
1-piece Urostomy Pouch, Soft Convex, Ceraplus
Manufacturer
Hollister IncorporatedModel number
8413Catalog number
8413
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Male
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE HOLLISTER PREMIER OSTOMY PRODUCT FOR YEARS DEVELOPED A PRESSURE WOUND AND BECAME SEPTIC. IT WAS FURTHER REPORTED THAT HE HAD BEEN IN AND OUT OF REHAB AND THE HOSPITAL FOR QUITE SOME TIME. NO FURTHER INFORMATION IS KNOWN.
Additional Manufacturer Narrative
THE OSTOMY APPLIANCE WAS NOT RETURNED; 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 BECAUSE A 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 PORTION OF THE UDI INFORMATION IS KNOWN DUE TO LACK OF LOT NUMBER INFORMATION.