ESTEEM+ 416751Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 1/2" (38Mm) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00768455112210), received between Aug 11, 2020 and Aug 11, 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 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389798 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389797 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389796 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389794 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389792 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389791 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389790 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389789 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389788 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389787 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389786 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389766 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389765 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389763 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389735 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389734 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389733 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389732 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389731 ↗MalfunctionAug 11, 2020Malposition of Device; Malposition of Device
THE PATIENT BROUGHT HIM 2 UNITS OF WAFERS AND ALL HAD STARTER HOLES OFF CENTERED. THE PRODUCTS WERE NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10389730 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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