ACTIVELIFE 175778Recalls & reported problems
Convatec, Purchasing Department · Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans, W/1 Sided Comfort Panel W/Tape Collar, 7/8" (22 Mm.) · Class 1
All models of ACTIVELIFE (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ConvaTec Activelife pouch is a one-piece colostomy pouch. Reports mostly describe an off-center stoma opening that makes the pouch unusable, with sharp edges in 1 report. There are 40 reports, all describing malfunctions, with no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00768455102525), received between Nov 27, 2018 and May 20, 2022 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (39 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 Device39
- Sharp Edges1
Patient problems
- No Consequences Or Impact To Patient16
- Distress15
- No Patient Involvement7
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER STOMA OPENING WAS OFF CENTERED DUE TO WHICH SHE WAS UNABLE TO USE THE WAFERS. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14460675 ↗MalfunctionNov 25, 2021Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12874045 ↗MalfunctionJun 1, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS DEFECTIVE AS IT WAS OFF CENTERED. THE PRODUCTS WERE NOT USED ON PATIENTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10104483 ↗MalfunctionJun 1, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS DEFECTIVE AS IT WAS OFF CENTERED. THE PRODUCTS WERE NOT USED ON PATIENTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10104482 ↗MalfunctionJun 1, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS DEFECTIVE AS IT WAS OFF CENTERED. THE PRODUCTS WERE NOT USED ON PATIENTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10104469 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041812 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041811 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041810 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041809 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041808 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041807 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041806 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041805 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041804 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041803 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041802 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041797 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041796 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041794 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER NOTED OFF CENTERED STARTER HOLES ON 15 POUCHES FROM 6 BOXES. NOT ONLY WAS THE FLANGE, BANDAGE AND POUCH OFF-CENTERED, BUT THE BANDAGE WAS ALSO CUT OFF CENTERED. SO, THERE WAS MORE BANDAGE AREA ON ONE SIDE AND LESS ON THE OTHER. REPORTEDLY, 1 FROM BOX #1, 2 FROM BOX #2, 5 FROM BOX #3, 1 FROM BOX #4, 5 FROM BOX #5 AND 1 FROM BOX #6 WERE AFFECTED. THE END USER FELT DISHEARTENED AND RELUCTANT TO USE THE PRODUCTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: Distress
MAUDE report 10041792 ↗MalfunctionMay 13, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8603181 ↗MalfunctionMay 13, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8603156 ↗MalfunctionMay 13, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8603135 ↗MalfunctionMay 13, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8603133 ↗MalfunctionDec 6, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED 13 POUCHES FROM 4 MARKET UNITS, ALL WITH THE SAME LOT, HAD THE MASS OFF CENTER. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8139295 ↗
Other POUCH, COLOSTOMY devices
- ACTIVELIFE 175777Convatec, Purchasing Department · POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175779Convatec, Purchasing Department · POUCH, COLOSTOMY39 reports
- ESTEEM SYNERGY+ 416779Convatec, Purchasing Department · POUCH, COLOSTOMY30 reports
- ACTIVELIFE 175782Convatec, Purchasing Department · POUCH, COLOSTOMY19 reports
- FLEXI-SEAL 418000Convatec, Purchasing Department · POUCH, COLOSTOMY16 reports
- ACTIVELIFE 175780Convatec, Purchasing Department · POUCH, COLOSTOMY10 reports
- ACTIVELIFE 175784Convatec, Purchasing Department · POUCH, COLOSTOMY5 reports
- NATURA 420696Convatec, Purchasing Department · POUCH, COLOSTOMY1 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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