ACTIVELIFE 175780Recalls & 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, 1 1/8" (28 Mm. · Class 1
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455102549), received between Feb 19, 2020 and Feb 19, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (10 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Malposition of Device10
Patient problems
- No Patient Involvement10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724648 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724644 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724643 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724641 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724640 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724639 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724616 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724615 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724614 ↗MalfunctionFeb 19, 2020Malposition of Device; Malposition of Device
THE NURSE RECEIVED 2 MARKET UNITS IN WHICH 5 POUCHES IN EACH BOX HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9724612 ↗
Other POUCH, COLOSTOMY devices
- ACTIVELIFE 175777Convatec, Purchasing Department · POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175778Convatec, 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 175784Convatec, Purchasing Department · POUCH, COLOSTOMY5 reports
- ESTEEM 423690Convatec, Purchasing Department · Pouch, colostomy1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.