Premier 8961Recalls & reported problems
Hollister Incorporated · 1-Piece Drainable Ostomy Pouch, Soft Convex, CeraPlus · 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 00610075057092), received between Nov 1, 2024 and Nov 1, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Rash1
- 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.
InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN END USER HAD A SKIN REACTION TO THE HOLLISTER CERAPLUS OSTOMY BARRIER. IT WAS REPORTED THAT THE END USER TRIED TO WEAR EACH BARRIER FOR 7 DAYS LIKE SHE DID WITH A PREVIOUS TYPE OF BARRIER BUT WHEN SHE CHANGED HER CERAPLUS BARRIER, THE SKIN HAD RED RAISED SPOTS. SHE REPORTED THAT HER HEALTHCARE PROFESSIONAL DID A BIOPSY THAT CAME BACK AS INFLAMED KERATOSIS-LIKE GROWTHS, AND NO CANCER WAS DETECTED. SHE THEN REPORTED THAT THE WOCN FELT SHE WAS REACTING TO THE CERAPLUS INGREDIENTS, SWITCHED HER TO A NON CERAPLUS HOLLISTER BARRIER, AND HAD HER USE CLOBETASOL TOPICALLY, AND HER SKIN HAS NOW HEALED.
Patient problems: Rash; Skin Inflammation/ Irritation
MAUDE report 20586004 ↗
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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