ACTIVELIFE 175792Recalls & reported problems
Convatec, Purchasing Department · Activelife® Convex One-Piece Urostomy Pouch With Durahesive® Skin Barrier, Trans Std, 3/4" (19 Mm.) · Class 1
All models of ACTIVELIFE (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00768455102624), received between Apr 18, 2019 and Jun 3, 2020 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (19 reports).
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
- Malposition of Device19
- Fluid/Blood Leak4
Patient problems
- No Consequences Or Impact To Patient19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2020Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN WAFERS FROM 2 BOXES OF 5. THE END USER DID TRY TO USE SOME OF THESE PRODUCTS AND EXPERIENCED LEAKAGE WITHIN HOURS OF APPLICATION. THERE WAS NO HARM REPORTED AND PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10113738 ↗MalfunctionJun 3, 2020Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN WAFERS FROM A BOX OF 5. THE END USER DID TRY TO USE SOME OF THESE PRODUCTS AND EXPERIENCED LEAKAGE WITHIN HOURS OF APPLICATION. THERE WAS NO HARM REPORTED AND PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10113734 ↗MalfunctionJun 3, 2020Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
THIS EMDR IS FOR AN UNKNOWN ADDITIONAL QUANTITY OF WAFERS. IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN WAFERS FROM 2 BOXES OF 5. THE END USER DID TRY TO USE SOME OF THESE PRODUCTS AND EXPERIENCED LEAKAGE WITHIN HOURS OF APPLICATION. THERE WAS NO HARM REPORTED AND PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10113733 ↗MalfunctionJun 3, 2020Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
THIS EMDR IS FOR AN UNKNOWN ADDITIONAL QUANTITY OF WAFERS. IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN WAFERS FROM A BOX OF 5. THE END USER DID TRY TO USE SOME OF THESE PRODUCTS AND EXPERIENCED LEAKAGE WITHIN HOURS OF APPLICATION. THERE WAS NO HARM REPORTED AND PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10113732 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527689 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527371 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527328 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527327 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527326 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527322 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527281 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527279 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527278 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527277 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527238 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527236 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527235 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527234 ↗MalfunctionApr 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527185 ↗
Other BAG, URINE COLLECTING, URETEROSTOMY devices
- Premier 8440Hollister Incorporated · BAG, URINE COLLECTING, URETEROSTOMY1 report
- 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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