Premier 8512Recalls & 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 00610075085125), received between Sep 30, 2024 and Sep 30, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE LOCK 'N ROLL CLOSER AT THE BOTTOM OF THE HOLLISTER OSTOMY POUCH OPENED IN USE AND THE ILEOSTOMY FECAL MATERIAL LEAKED OUT. IT WAS FURTHER REPORTED THAT THE LEAKAGE GOT ON THE END USER'S LOWER ABDOMEN AND UPPER LEG AREA. IT WAS REPORTED THAT THE END USER THEN DEVELOPED A UTI AND THE END USER CONCLUDED THAT IT MUST HAVE BEEN FROM THE FECAL MATTER THAT LEAKED, CONTAMINATING HIS PENIS AREA. IT WAS REPORTED THAT THE END USER WENT TO THE ER WHERE THE UTI DIAGNOSIS WAS MADE, THEY DID NOT INDICATE WHAT CAUSED OR CONTRIBUTED TO THE UTI, AND THEY PRESCRIBED A 10-DAY COURSE OF ANTIBIOTICS TO TREAT THE UTI. ADDITIONALLY, IT WAS REPORTED THAT NOW, 4 DAYS LATER, HE IS FEELING BETTER AND HOLLISTER IS PROVIDING HIM SAMPLES OF AN OSTOMY POUCH WITH A DIFFERENT TYPE OF CLOSURE TO TRY.
Patient problems: Urinary Tract Infection
MAUDE report 20335559 ↗
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 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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