ACTIVELIFE 175791Recalls & reported problems
Convatec, Purchasing Department · Activelife® Convex One-Piece Urostomy Pouch With Durahesive® Skin Barrier, Trans Std, 5/8" (16 Mm.) · Class 1
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00768455102617), received between Aug 23, 2022 and May 5, 2023 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (22 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 Device22
Patient problems
- No Clinical Signs, Symptoms or Conditions22
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2023Malposition 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 16874264 ↗MalfunctionMay 5, 2023Malposition 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 16874263 ↗MalfunctionMay 5, 2023Malposition 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 16874261 ↗MalfunctionMay 5, 2023Malposition 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 16874260 ↗MalfunctionMay 5, 2023Malposition 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 16874259 ↗MalfunctionMay 5, 2023Malposition 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 16874258 ↗MalfunctionMay 5, 2023Malposition 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 16874257 ↗MalfunctionMay 5, 2023Malposition 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 16874256 ↗MalfunctionMay 5, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT HE HAD FIVE MARKET UNITS OF COMPANY¿S KNOWN PRECUT OPENING POUCHES AND MOST OF THEM WERE OFF-CENTERED TO ONE DEGREE OR ANOTHER. HE STATED THAT APPROXIMATELY ONE-HALF TO TWO-THIRD WERE VERY OFF-CENTERED. HE ALSO MENTIONED THAT HE MIGHT BE ABLE TO USE JUST A HANDFUL FROM THESE FIVE BOXES. HE DID NOT WISH TO COUNT EVERY POUCH, BUT VERIFIED THAT HE HAD EXAMINED SOME IN EACH MARKET UNIT. FURTHERMORE, HE STATED THAT HE WILL SEND A PHOTO, HOWEVER AT THIS TIME, NO PHOTO RECEIVED. HE HAD NOT USED THE ONES THAT WERE OFF-CENTERED. HE ONLY USED THE ONE THAT HE FEELS LIKE WERE SAFE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874240 ↗MalfunctionMay 5, 2023Malposition 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 16874239 ↗MalfunctionMay 5, 2023Malposition 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 16874238 ↗MalfunctionMay 5, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT HE HAD FIVE MARKET UNITS OF COMPANY¿S KNOWN PRECUT OPENING POUCHES AND MOST OF THEM WERE OFF-CENTERED TO ONE DEGREE OR ANOTHER. HE STATED THAT APPROXIMATELY ONE-HALF TO TWO-THIRD WERE VERY OFF-CENTERED. HE ALSO MENTIONED THAT HE MIGHT BE ABLE TO USE JUST A HANDFUL FROM THESE FIVE BOXES. HE DID NOT WISH TO COUNT EVERY POUCH, BUT VERIFIED THAT HE HAD EXAMINED SOME IN EACH MARKET UNIT. FURTHERMORE, HE STATED THAT HE WILL SEND A PHOTO, HOWEVER AT THIS TIME, NO PHOTO RECEIVED. HE HAD NOT USED THE ONES THAT WERE OFF-CENTERED. HE ONLY USED THE ONE THAT HE FEELS LIKE WERE SAFE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874237 ↗MalfunctionMay 5, 2023Malposition 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 16874236 ↗MalfunctionMay 5, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT HE HAD FIVE MARKET UNITS OF COMPANY¿S KNOWN PRECUT OPENING POUCHES AND MOST OF THEM WERE OFF-CENTERED TO ONE DEGREE OR ANOTHER. HE STATED THAT APPROXIMATELY ONE-HALF TO TWO-THIRD WERE VERY OFF-CENTERED. HE ALSO MENTIONED THAT HE MIGHT BE ABLE TO USE JUST A HANDFUL FROM THESE FIVE BOXES. HE DID NOT WISH TO COUNT EVERY POUCH, BUT VERIFIED THAT HE HAD EXAMINED SOME IN EACH MARKET UNIT. FURTHERMORE, HE STATED THAT HE WILL SEND A PHOTO, HOWEVER AT THIS TIME, NO PHOTO RECEIVED. HE HAD NOT USED THE ONES THAT WERE OFF-CENTERED. HE ONLY USED THE ONE THAT HE FEELS LIKE WERE SAFE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874235 ↗MalfunctionMay 5, 2023Malposition 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 16874234 ↗MalfunctionMay 5, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT HE HAD FIVE MARKET UNITS OF COMPANY¿S KNOWN PRECUT OPENING POUCHES AND MOST OF THEM WERE OFF-CENTERED TO ONE DEGREE OR ANOTHER. HE STATED THAT APPROXIMATELY ONE-HALF TO TWO-THIRD WERE VERY OFF-CENTERED. HE ALSO MENTIONED THAT HE MIGHT BE ABLE TO USE JUST A HANDFUL FROM THESE FIVE BOXES. HE DID NOT WISH TO COUNT EVERY POUCH, BUT VERIFIED THAT HE HAD EXAMINED SOME IN EACH MARKET UNIT. FURTHERMORE, HE STATED THAT HE WILL SEND A PHOTO, HOWEVER AT THIS TIME, NO PHOTO RECEIVED. HE HAD NOT USED THE ONES THAT WERE OFF-CENTERED. HE ONLY USED THE ONE THAT HE FEELS LIKE WERE SAFE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874233 ↗MalfunctionMay 5, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT HE HAD FIVE MARKET UNITS OF COMPANY¿S KNOWN PRECUT OPENING POUCHES AND MOST OF THEM WERE OFF-CENTERED TO ONE DEGREE OR ANOTHER. HE STATED THAT APPROXIMATELY ONE-HALF TO TWO-THIRD WERE VERY OFF-CENTERED. HE ALSO MENTIONED THAT HE MIGHT BE ABLE TO USE JUST A HANDFUL FROM THESE FIVE BOXES. HE DID NOT WISH TO COUNT EVERY POUCH, BUT VERIFIED THAT HE HAD EXAMINED SOME IN EACH MARKET UNIT. FURTHERMORE, HE STATED THAT HE WILL SEND A PHOTO, HOWEVER AT THIS TIME, NO PHOTO RECEIVED. HE HAD NOT USED THE ONES THAT WERE OFF-CENTERED. HE ONLY USED THE ONE THAT HE FEELS LIKE WERE SAFE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874232 ↗MalfunctionAug 23, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT FIVE WAFERS WITH STARTER HOLE WERE OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15274682 ↗MalfunctionAug 23, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT FIVE WAFERS WITH STARTER HOLE WERE OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15274680 ↗MalfunctionAug 23, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT FIVE WAFERS WITH STARTER HOLE WERE OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15274613 ↗MalfunctionAug 23, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT FIVE WAFERS WITH STARTER HOLE WERE OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15274611 ↗MalfunctionAug 23, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT FIVE WAFERS WITH STARTER HOLE WERE OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15274609 ↗
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.