ACTIVELIFE 175777Recalls & 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, 3/4" (19 Mm.) · Class 1
Quick summary
This Activelife colostomy pouch has 40 adverse event reports, all describing malfunctions, with no deaths or injuries. Reports mostly describe the pouch sitting off-center or separating from the skin barrier, sometimes causing odor or skin damage. There are no recalls for this device. Reports rose to 10 in the last 12 months from 0 in the previous 12 months.
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 00768455102518), received between Mar 18, 2019 and Nov 20, 2025 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (40 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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device40
- Peeled/Delaminated5
- Positioning Failure5
Patient problems
- No Consequences Or Impact To Patient15
- Tissue Damage15
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602270 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
THE CONSUMER¿S WIFE REPORTED THAT THE MASS WAS OFF-CENTER. THERE WERE FIVE POUCHES FROM THIS BOX. SHE STATED THAT SHE HAD NOT USED ANY FROM THIS BOX BECAUSE OF FEAR THAT THE POUCH WOULD SEPARATE FROM THE MASS. PHOTOS WERE REQUESTED, AND A REPLACEMENT WAS PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602268 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602267 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
THE CONSUMER¿S WIFE REPORTED THAT THE MASS WAS OFF-CENTER. THERE WERE FIVE POUCHES FROM THIS BOX. SHE STATED THAT SHE HAD NOT USED ANY FROM THIS BOX BECAUSE OF FEAR THAT THE POUCH WOULD SEPARATE FROM THE MASS. PHOTOS WERE REQUESTED, AND A REPLACEMENT WAS PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602266 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
THE CONSUMER¿S WIFE REPORTED THAT THE MASS WAS OFF-CENTER AND THE POUCH DETACHED FROM THE MASS AS A RESULT, CAUSING ODOR. THERE WERE FIVE POUCHES FROM THIS BOX. SHE STATED THAT ALL WERE OFF-CENTER, BUT THREE HAD BEEN USED AND WERE SLIGHTLY SEPARATED FROM THE MASS. THEY SEEMED TO CATCH THE ISSUE BEFORE LEAKAGE OF EFFLUENT OCCURRED. THE MASS REMAINED ADHERED WELL TO THE SKIN. THE CONSUMER USED AN APPLIANCE BELT AND PLACED ODOR ELIMINATOR DROPS IN THE POUCH. ACCORDING TO THE CASE HISTORY, SHE MENTIONED THIS HAD BEEN AN ONGOING ISSUE, WHICH WAS RESOLVED FOR A WHILE BUT HAD STARTED OCCURRING AGAIN. SHE ALSO REPORTED A SECOND LOT ON THE SAME DAY. PHOTOS WERE REQUESTED, AND A REPLACEMENT WAS PROVIDED. NO HARM WAS REPORTED, BUT THEY INDICATED HAVING TO USE MANY MORE POUCHES THAN TYPICAL (WEAR TIME COULD BE ALMOST A WEEK WHEN THIS ISSUE WAS NOT OCCURRING). THE CONSUMER HAD BEEN USING THE PRODUCT FOR MANY YEARS. NO PHOTO WAS AVAILABLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602265 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602264 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602263 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602262 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602207 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602205 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432691 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432689 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432641 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432628 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432627 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432549 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432224 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432164 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432161 ↗MalfunctionMar 19, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THE STARTER HOLE WAS OFF-CENTER. SHE FURTHER REPORTED SHE HAD DECREASED WEAR TIME, AND AS A RESULT HAS A TINY AREA OF DENUDED SKIN DUE TO THE FREQUENT APPLIANCE CHANGE. SHE USUALLY CHANGES HER APPLIANCE EVERY 7-10 DAYS BUT SHE HAD TO CHANGE THIS WITHIN 1 DAY. NO FURTHER INFORMATION OR PHOTOGRAPH WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 8432158 ↗MalfunctionMar 18, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN 15 WAFERS. NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429362 ↗MalfunctionMar 18, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN 15 WAFERS. NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429354 ↗MalfunctionMar 18, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN 15 WAFERS. NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429353 ↗MalfunctionMar 18, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN 15 WAFERS. NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429292 ↗MalfunctionMar 18, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN 15 WAFERS. NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429291 ↗
Other POUCH, COLOSTOMY devices
- 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 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.