ESTEEM+ 416742Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 1" (25Mm) · Class 1
All models of ESTEEM (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00768455112128), received between Jun 21, 2019 and Apr 23, 2020 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Malposition of Device14
- Positioning Problem4
Patient problems
- No Patient Involvement10
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER REPORTED THAT 4 OUT OF 10 APPLIANCES HAD AN OFF CENTERED WAFER STOMA OPENING. THE AFFECTED WAFERS HAD A DECREASED WEAR TIME OF 1 DAY. THERE WAS NO HARM REPORTED BY THE END USER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989324 ↗MalfunctionApr 23, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER REPORTED THAT 4 OUT OF 10 APPLIANCES HAD AN OFF CENTERED WAFER STOMA OPENING. THE AFFECTED WAFERS HAD A DECREASED WEAR TIME OF 1 DAY. THERE WAS NO HARM REPORTED BY THE END USER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989313 ↗MalfunctionApr 23, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER REPORTED THAT 4 OUT OF 10 APPLIANCES HAD AN OFF CENTERED WAFER STOMA OPENING. THE AFFECTED WAFERS HAD A DECREASED WEAR TIME OF 1 DAY. THERE WAS NO HARM REPORTED BY THE END USER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989312 ↗MalfunctionApr 23, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER REPORTED THAT 4 OUT OF 10 APPLIANCES HAD AN OFF CENTERED WAFER STOMA OPENING. THE AFFECTED WAFERS HAD A DECREASED WEAR TIME OF 1 DAY. THERE WAS NO HARM REPORTED BY THE END USER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989310 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723753 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723517 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723468 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723466 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723465 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723464 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723411 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723410 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723409 ↗MalfunctionJun 21, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER IN TEN WAFERS. NO PHOTO PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8723360 ↗
Other Bag, drainage, with adhesive, ostomy devices
- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423657Convatec, 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 423665Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423646Convatec, 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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