ESTEEM+ 421626Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V2 Cut-To-Fit, 10-35Mm · Class 1
All models of ESTEEM (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455143436), received between Aug 25, 2021 and Aug 25, 2021 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (7 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 16, 2026.
Most reported problems
Device problems
- Sharp Edges7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365091 ↗MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365047 ↗MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365046 ↗MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365044 ↗MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365042 ↗MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365039 ↗MalfunctionAug 25, 2021Sharp Edges; Sharp Edges
THE END USER'S WIFE REPORTED THAT THE EDGE OF THE OPENING WAS ROUGH INSTEAD OF SMOOTH IN 7 OUT OF 10 APPLIANCES. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12365038 ↗
Other BAG, URINARY, ILEOSTOMY devices
- ESTEEM 423727Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall1 report
- ESTEEM 423726Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423714Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423716Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423704Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423712Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423723Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423713Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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