New Image 14904Recalls & reported problems
Hollister Incorporated · 2-Piece Ostomy Skin Barrier, Convex, Flextend · Class 1
All models of New Image (19)
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 00610075149049), received between Mar 14, 2024 and Mar 14, 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
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TAPE BORDER ON THE NEW IMAGE OSTOMY BARRIER IRRITATED THE END USER'S SKIN. IT WAS REPORTED THAT THE END USER HAS HISTORY OF SENSITIVITY TO ADHESIVES BUT NEVER HAD ANY ISSUE IN THE PAST WITH THIS SKU. IT WAS REPORTED THAT A FEW MONTHS AGO, THE END USER'S SKIN BECAME IRRITATED AND ITCHY AND THAT SHE NEEDED TO CHANGE THE BARRIER EVERY DAY. IT WAS FURTHER REPORTED THAT SHE SAW HER DOCTOR WHO SAID SHE SHOULD USE THE OVER-THE-COUNTER ANTIFUNGAL CREAM, LOTRIMIN, AND TO USE THE PRESCRIPTIVE STEROID CREAM, TRIAMCINOLONE 0.1% FOR THE IRRITATED AREA. IT WAS REPORTED THAT THE END USER SWITCHED BARRIER PRODUCTS AND ALONG WITH THE CREAMS, THE IRRITATED SKIN UNDER THE TAPE BORDER HAS NOW CLEARED UP.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18907812 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page