New Image 18004Recalls & reported problems
Hollister Incorporated · 2-Piece Drainable Ostomy Pouch · 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 00610075113965), received between Aug 26, 2026 and Aug 26, 2026 — 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
- 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.
InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the user experienced skin irritation associated with use of Hollister New Image 2-Piece Drainable Ostomy Pouch. It was reported that the fabric material of product 18004 was perceived to be heavier, rubbed against the skin, caused redness in areas of contact, and was more difficult to empty. It was also reported that the user began wearing undergarments and using a belt to reduce contact between the pouch and the skin. It was reported that the user had a large hernia, a prolapsed stoma, and an increase in stoma size. It was reported that the user had been evaluated by a nurse and physician and was being treated with prescribed Nystatin powder for a suspected yeast-related skin condition; however, the treatment reportedly did not improve the symptoms. It was also reported that the nurse believed the condition to be dermatitis. It was reported that the symptoms remained ongoing at the time of the report. It was also reported that medical intervention was required, including evaluation by healthcare professionals and treatment with prescribed Nystatin powder.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50451162 ↗
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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