Premier 8331Recalls & reported problems
Hollister Incorporated · 1-Piece Drainable Ostomy Pouch, Flextend · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075168576), received between Mar 16, 2023 and Sep 25, 2023 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blister1
- Skin Erosion1
- Skin Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO WAS PLACED IN THE HOLLISTER PREMIER OSTOMY BARRIER EXPERIENCED A FUNGAL SKIN INFECTION UNDER THE BARRIER. IT WAS REPORTED THAT THE ER TOLD HIM TO CHANGE THE BARRIER 4X A DAY AND USE KETOCONAZOLE 2% AND TRIAMCINOLONE.
Patient problems: Skin Infection
MAUDE report 17809611 ↗InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE END USER'S SUPPLIER COULD NOT SUPPLY HER USUAL HOLLISTER CONVEX OSTOMY BARRIER POUCHING SYSTEM SO THEY PROVIDED HER WITH A FLAT HOLLISTER OSTOMY POUCHING SYSTEM. THE END USER REPORTED THAT THIS HAD BEEN GOING ON FOR ABOUT 2 MONTHS. END USER REPORTED THAT SINCE HER STOMA WAS FLUSH TO THE SKIN, THIS ALLOWED EFFLUENT LEAKAGE UNDER THE BARRIER WHICH LED TO THE NEED FOR FREQUENT OSTOMY APPLIANCE CHANGES. END USER FURTHER REPORTED THAT THE FREQUENT CHANGES LEAD TO 4 SKIN ULCERS/BLISTERS UNDER THE BARRIER. END USER REPORTED THAT ONE BLISTER BROKE OPEN AND BLOOD AND PUS CAME OUT. SHE REPORTED THAT SHE WENT TO THE ED WHO PROVIDED HER A PASTE AND ORAL ANTIBIOTICS. HOLLISTER WILL PROVIDE SAMPLES OF HER CONVEX POUCHING SYSTEM TO TIDE HER OVER UNTIL SHE CAN GET THAT PRODUCT FROM HER SUPPLIER.
Patient problems: Blister; Skin Erosion
MAUDE report 16558428 ↗
Other COLLECTOR, OSTOMY devices
- New Image 11704Hollister Incorporated · COLLECTOR, OSTOMY4 reports
- New Image 14803Hollister Incorporated · COLLECTOR, OSTOMY3 reports
- New Image 11504Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 14603Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11703Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11203Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8512Hollister Incorporated · COLLECTOR, OSTOMY1 report
- Premier 88400Hollister Incorporated · COLLECTOR, OSTOMY1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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