Premier 8958Recalls & 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 00610075057078), received between May 7, 2026 and May 7, 2026 — 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
- 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.
InjuryMay 7, 2026Leak/Splash
IT WAS REPORTED THAT AN END USEDR WAS PLACED IN HOLLISTER PREMIER OSTOMY POUCHING SYSTEM 8958 AFTER SURGERY AND WENT TO A REHAB TO RECOVER. IT WAS REPORTED THAT WHILE IN REHAB, WHEN HER OSTOMY POUCH WAS FULL, THE STAFF, BEING UNDERSTAFFED, DID NOT TEND TO HER OSTOMY NEEDS PROMPTLY. SHE REPORTED THAT IT LED TO EFFLUENT LEAKAGE UNDER THE BARRIER WHICH LED TO SKIN IRRITATION AND PERISTOMAL SKIN WOUNDS. IT WAS FURTHER REPORTED THAT SHE WAS HOSPITALIZED TO RECEIVE WOUND CARE FOR THESE WOUNDS AND IS SCHEDULED FOR A STOMAL REVERSAL NEXT WEEK.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25117564 ↗
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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