Premier 8440Recalls & reported problems
Hollister Incorporated · 1-Piece Urostomy 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 00610075000975), received between Mar 16, 2017 and Mar 16, 2017 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2017Adverse Event Without Identified Device or Use Problem
PT HAD A 0.5 CM X 2.0CM UNSTAGEABLE PRESSURE INJURY TO THE UPPER LIP/MUSTACHE. HAD THE ANCHOR FAST DEVICE ON. REQUIRED DEBRIDEMENT AND SURGICAL CLOSURE BY PLASTIC SURGERY. THE PRODUCT WAS APPLIED TO THE PATIENT ON (B)(6) 2017 AND THE DATE OF THE INJURY WAS (B)(6)2017.
Patient problems: Injury
MAUDE report 6416701 ↗
Other BAG, URINE COLLECTING, URETEROSTOMY devices
- ACTIVELIFE 175792Convatec, Purchasing Department · BAG, URINE COLLECTING, URETEROSTOMY19 reports
- Premier 8442Hollister Incorporated · BAG, URINE COLLECTING, URETEROSTOMY1 report
- Premier 8413Hollister Incorporated · BAG, URINE COLLECTING, URETEROSTOMY1 report
- Premier 8414Hollister Incorporated · BAG, URINE COLLECTING, URETEROSTOMY1 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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