ESTEEM+ 413522Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (30/40M · Class 1
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455130245), received between Dec 2, 2019 and Dec 2, 2019 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (10 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 Device10
Patient problems
- No Consequences Or Impact To Patient10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2019Malposition 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 9394276 ↗MalfunctionDec 2, 2019Malposition 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 9394272 ↗MalfunctionDec 2, 2019Malposition 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 9394270 ↗MalfunctionDec 2, 2019Malposition 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 9394269 ↗MalfunctionDec 2, 2019Malposition 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 9394258 ↗MalfunctionDec 2, 2019Malposition 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 9394256 ↗MalfunctionDec 2, 2019Malposition 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 9394255 ↗MalfunctionDec 2, 2019Malposition 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 9394254 ↗MalfunctionDec 2, 2019Malposition 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 9394253 ↗MalfunctionDec 2, 2019Malposition 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 9394246 ↗
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.