Premier 8538Recalls & reported problems
Hollister Incorporated · 1-Piece Drainable Ostomy Pouch, Flextend · 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 00610075085385), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- Tissue Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT AN END USER WAS USING A PRE CUT 32MM HOLLISTER OSTOMY POUCHING SYSTEM AND WAS STRETCHING IT WITH HIS FINGERS TO MAKE IT LARGE ENOUGH TO FIT OVER THE STOMA EVEN THOUGH IT WAS TOO SMALL. IT WAS REPORTED THAT THE END USER CUT HIS STOMA BY DOING THIS AND ENDED UP IN THE ER. IT WAS FURTHER REPORTED THAT FIRST THE OSTOMY CLINIC TRIED USING SILVER NITRATE ON THE WOUND, WHICH CAUSED THE END USER TO PASS OUT. IT WAS REPORTED THAT THE END USER WAS THEN ADMITTED TO THE ER WHERE THEY STITCHED THE WOUND CLOSED. A POUCHING SYSTEM WITH A LARGER PRE CUT OPENING SIZE HAS SINCE BEEN ORDERED.
Patient problems: Tissue Irritation
MAUDE report 24606928 ↗
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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