ACTIVELIFE 125365Recalls & reported problems
Convatec, Purchasing Department · Activelife® Convex One-Piece Pre-Cut Urostomy Pouch With Durahesive® Skin Barrier, Trans Std, 1" (25Mm.) · Class 1
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00768455102181), received between Aug 25, 2020 and Aug 25, 2020 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (20 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 Device20
Patient problems
- No Consequences Or Impact To Patient20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446809 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446808 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446807 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446806 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446805 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446804 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446803 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446802 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446801 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446800 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446799 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446790 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446789 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446788 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446787 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446786 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446785 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446784 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446783 ↗MalfunctionAug 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT 20 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD THE PRECUT OPENING OFF-CENTERED. SOMETIMES, IT WAS MORE TO THE RIGHT OR LEFT OR TOP VERSUS BOTTOM. IT WAS CONFIRMED THAT NONE OF THE PRODUCTS WERE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10446782 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.