ESTEEM+ 416747Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/4" (32Mm) · Class 1
Quick summary
This is a Convatec Esteem+ convex one-piece drainable ostomy pouch with a pre-cut opening and Velcro straps. The 35 reports mostly describe the pouch not sitting or staying in the right position, and rough or jagged edges on the Velcro straps that wear on the skin and were described as leading to leg sores. There are no deaths and no injuries reported. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00768455112173), received between Nov 13, 2018 and Feb 21, 2025 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (25 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 Device25
- Sharp Edges10
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient19
- Pressure Sore/Ulcer10
- No Patient Involvement5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431366 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431365 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431364 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431361 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431321 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431317 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431316 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431315 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431313 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431310 ↗MalfunctionAug 12, 2022Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
IT WAS REPORTED THAT THE WAFER STARTER HOLE WAS OFF CENTERED AND HAD INSUFFICIENT ADHESION ON ONE SIDE. THE PRODUCT WAS USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15216017 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647583 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647377 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647376 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647375 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647364 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647351 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647350 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647349 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647348 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647347 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647346 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647345 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647344 ↗MalfunctionOct 8, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10647343 ↗
Other Bag, drainage, with adhesive, ostomy devices
- ESTEEM 423657Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ACTIVELIFE 022767Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy60 reports
- ESTEEM+ 416740Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy55 reports
- ACTIVELIFE 022765Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy53 reports
- ESTEEM 423646Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423665Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.