Premier 88400Recalls & reported problems
Hollister Incorporated · 1-Piece Drainable Ostomy Pouch, SoftFlex · 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 00610075106509), received between Jul 11, 2024 and Jul 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE END USER HAD BEEN EXPERIENCING IRRITATION AROUND THE STOMA UNDER THE HOLLISTER PREMIER BARRIER FOR A WHILE DUE TO LEAKAGE OF OUTPUT AND WENT TO THE ER IN MAY. IT WAS REPORTED THAT THE ER SAID TO USE THE NO STING GEL AND CREAM (PROVIDED BY THE ER), THEN POWDER UNDER THE BARRIER. IT WAS REPORTED THAT THE END USER WAS PRESCRIBED CLOTRIMAZOLE BETAMETHASONE CREAM 15 GM AND LIDOCAINE HYDROCHLORIDE GEL 100 MG. IT WAS REPORTED THAT THE END USER HAS CONTINUED TO USE THE PRESCRIBED TOPICAL MEDICATION WHENEVER THE SKIN IS IRRITATED FROM OUTPUT RESTING ON THE SKIN. IT WAS FURTHER REPORTED THAT THE END USER CALLED HOLLISTER BECAUSE THEY WERE RUNNING OUT OF OSTOMY SUPPLIES FROM FREQUENT APPLIANCE CHANGES AND HOLLISTER IS SENDING OUT SAMPLES OF DIFFERENT PRODUCTS FOR THEM TO TRY IN ORDER TO SEE IF IT WORKS BETTER FOR THEM.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 19724028 ↗
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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