ACTIVELIFE 650831Recalls & reported problems
Convatec, Purchasing Department · Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1 1/8" (28 Mm.) · Class 1
Quick summary
This is a Convatec ActiveLife one-piece urostomy pouch, a bag worn on the abdomen to drain urine after urostomy surgery. The 44 reports all describe the same issue: the starter hole, which is cut to fit the body's opening, being off-center so the pouch does not fit properly. None describe injuries or deaths, 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
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00768455106646), received between Dec 19, 2018 and Oct 23, 2020 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (44 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 Device44
Patient problems
- No Consequences Or Impact To Patient34
- No Patient Involvement10
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT THE OPENING OF 6 POUCHES WAS OFF-CENTERED. THE PRODUCT WAS USED AND NO HARM WAS REPORTED. HE CHANGES EVERY 4 DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10726018 ↗MalfunctionOct 23, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT THE OPENING OF 6 POUCHES WAS OFF-CENTERED. THE PRODUCT WAS USED AND NO HARM WAS REPORTED. HE CHANGES EVERY 4 DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10725952 ↗MalfunctionOct 23, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT THE OPENING OF 6 POUCHES WAS OFF-CENTERED. THE PRODUCT WAS USED AND NO HARM WAS REPORTED. HE CHANGES EVERY 4 DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10725951 ↗MalfunctionOct 23, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT THE OPENING OF 6 POUCHES WAS OFF-CENTERED. THE PRODUCT WAS USED AND NO HARM WAS REPORTED. HE CHANGES EVERY 4 DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10725950 ↗MalfunctionOct 23, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT THE OPENING OF 6 POUCHES WAS OFF-CENTERED. THE PRODUCT WAS USED AND NO HARM WAS REPORTED. HE CHANGES EVERY 4 DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10725946 ↗MalfunctionOct 23, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT THE OPENING OF 6 POUCHES WAS OFF-CENTERED. THE PRODUCT WAS USED, AND NO HARM WAS REPORTED. HE CHANGES EVERY 4 DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10725945 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527525 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527524 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527523 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527522 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527520 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527482 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527481 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527480 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527479 ↗MalfunctionSep 14, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 10527476 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213736 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213733 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213724 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213652 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213642 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213630 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213527 ↗MalfunctionJan 3, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE PRE-CUT HOLE IS OFF CENTER IN EIGHT WAFERS. NO HARM REPORTED AND NO PHOTOS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8213472 ↗MalfunctionDec 19, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED TEN (10) POUCHES WITH PRE-CUT HOLE IS OFF CENTER. NO HARM REPORTED AND NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8180610 ↗
Other BAG, URINARY, ILEOSTOMY devices
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- ESTEEM 423717Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423705Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423726Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423704Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423714Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423716Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423722Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.