Premier 82711Recalls & reported problems
Hollister Incorporated · 1-Piece Drainable Ostomy Pouch, Convex, Flextend · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075055319), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Human-Device Interface Problem1
Patient problems
- Skin Erosion1
- Skin Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT THE END USER HAD LEAKAGE AND EXPERIENCED SKIN BREAK DOWN WITH USING THE HOLLISTER PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH - SOFT CONVEX FLEXTEND BARRIER. IT WAS REPORTED THAT THE END USER HAS A CREASE/FOLD IN HIS SKIN UNDERNEATH THE STOMA WHICH DOESN'T ALLOW FOR A GOOD SEAL AND ALLOWS THE ACCUMULATION OF EFFLUENT IN THIS CREASE. IT WAS REPORTED THAT THE END USER HAD BEEN SUFFERING WITH CROHN'S SINCE 1968. IT WAS FURTHER REPORTED THAT THE END USER SAW HIS WOUND CARE DOCTOR WHO DETERMINED BY CULTURE THAT HE HAD EIGHT DIFFERENT BACTERIA'S GROWING. IT WAS REPORTED THAT HE WAS PRESCRIBED TWO ANTIBIOTICS (ORAL MEDICATION AND LEVOQUIN AND FLAGIL WHICH IS COMPOUNDED INTO A SPRAY). IT WAS FURTHER REPORTED THAT HE WAS PROVIDED WITH DIFFERENT SAMPLES FROM HOLLISTER THAT HE IS TRYING NOW.
Patient problems: Skin Erosion; Skin Infection
MAUDE report 22965346 ↗
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 8331Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8512Hollister 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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