ACTIVELIFE 175779Recalls & 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" (25 Mm.) · Class 1
Quick summary
This Activelife colostomy pouch has 39 adverse event reports, all malfunctions with no deaths or injuries. Reports mostly describe pouch openings cut off-center, which shortened wear time from several days to about one day; some also mention skin irritation. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00768455102532), received between Oct 9, 2018 and Apr 30, 2019 — classified as 39 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Malposition of Device39
Patient problems
- No Consequences Or Impact To Patient20
- No Patient Involvement11
- Skin Irritation8
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE MASS WAS OFF CENTER WITH FIVE (5) POUCHES IN THE BOX. THREE WERE USED WITH A DECREASE IN WEAR TIME FROM 3-4 DAYS TO 1 DAY DUE TO MASS OFF CENTER. NO HARM REPORTED AND NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8566413 ↗MalfunctionApr 30, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE MASS WAS OFF CENTER WITH FIVE (5) POUCHES IN THE BOX. THREE WERE USED WITH A DECREASE IN WEAR TIME FROM 3-4 DAYS TO 1 DAY DUE TO MASS OFF CENTER. NO HARM REPORTED AND NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8565950 ↗MalfunctionApr 30, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE MASS WAS OFF CENTER WITH FIVE (5) POUCHES IN THE BOX. THREE WERE USED WITH A DECREASE IN WEAR TIME FROM 3-4 DAYS TO 1 DAY DUE TO MASS OFF CENTER. NO HARM REPORTED AND NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8565898 ↗MalfunctionApr 30, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE MASS WAS OFF CENTER WITH FIVE (5) POUCHES IN THE BOX. THREE WERE USED WITH A DECREASE IN WEAR TIME FROM 3-4 DAYS TO 1 DAY DUE TO MASS OFF CENTER. NO HARM REPORTED AND NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8565643 ↗MalfunctionApr 30, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE MASS WAS OFF CENTER WITH FIVE (5) POUCHES IN THE BOX. THREE WERE USED WITH A DECREASE IN WEAR TIME FROM 3-4 DAYS TO 1 DAY DUE TO MASS OFF CENTER. NO HARM REPORTED AND NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8565506 ↗MalfunctionApr 23, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED AN ISSUE WITH FIVE OUT OF FIVE PRECUT OSTOMY APPLIANCES, WHERE THE OPENING WAS CUT OFF CENTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540383 ↗MalfunctionApr 23, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED AN ISSUE WITH FIVE OUT OF FIVE PRECUT OSTOMY APPLIANCES, WHERE THE OPENING WAS CUT OFF CENTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540379 ↗MalfunctionApr 23, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED AN ISSUE WITH FIVE OUT OF FIVE PRECUTOSTOMY APPLIANCES, WHERE THE OPENING WAS CUT OFF CENTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540314 ↗MalfunctionApr 23, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED AN ISSUE WITH FIVE OUT OF FIVE PRECUT OSTOMY APPLIANCES, WHERE THE OPENING WAS CUT OFF CENTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540193 ↗MalfunctionApr 23, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED AN ISSUE WITH FIVE OUT OF FIVE PRECUT OSTOMY APPLIANCES, WHERE THE OPENING WAS CUT OFF CENTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540191 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424415 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424412 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424399 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424398 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424371 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424367 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424364 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424273 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424272 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424269 ↗MalfunctionMar 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED SHE RECEIVED "BAD" PRODUCT. THE PRODUCT WAS NOT USED. PHOTOGRAPHS WERE PROVIDED WHICH DEPICTED THE STARTER HOLE WAS OFF-CENTER.
Patient problems: No Patient Involvement
MAUDE report 8424226 ↗MalfunctionNov 30, 2018Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Skin Irritation
MAUDE report 8120971 ↗MalfunctionNov 30, 2018Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Skin Irritation
MAUDE report 8120970 ↗MalfunctionNov 30, 2018Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Skin Irritation
MAUDE report 8120969 ↗MalfunctionNov 30, 2018Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Skin Irritation
MAUDE report 8120968 ↗
Other POUCH, COLOSTOMY devices
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- ACTIVELIFE 175778Convatec, Purchasing Department · POUCH, COLOSTOMY40 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
- 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.