PREMIER
Received Nov 5, 2024 · Event occurred Oct 21, 2024
Report 1119193-2024-00020 · MDR key 20610410
Device
Generic name
1-piece Drainable Ostomy Pouch, Soft Convex, Flextend
Manufacturer
Hollister IncorporatedCatalog number
8578
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
81 YR · Female
- Blister
- Blister
Narrative
Additional Manufacturer Narrative
THE BARRIER 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. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE. REGARDING UDI INFORMATION, ONLY DI INFORMATION IS AVAILABLE AS THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER NOTICED SKIN IRRITATION UNDER THE TAPE BORDER OF THE HOLLISTER PREMIER SOFT CONVEX BARRIER. IT WAS REPORTED THAT THE SKIN WAS BUBBLY. IT WAS FURTHER REPORTED THAT THE END USER WENT TO THE DOCTOR WHO PRESCRIBED A POWDER. A DIFFERENT BARRIER WAS THEN RECOMMENDED WITHOUT A TAPE BORDER.