ESTEEM SYNERGY 411658Recalls & reported problems
Convatec, Purchasing Department · Esteem Synergy® Stomahesive® Moldable Skin Barrier - Medium, 48 Mm (22-33Mm Stoma Range) · Class 1
All models of ESTEEM SYNERGY (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Esteem Synergy moldable ostomy skin barrier has 105 reports, with no deaths and no injuries. All of the reports describe the opening in the barrier being off-center, and some describe leakage. Most patients were reported to have no consequences. 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
- 105
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00768455117345), received between Nov 19, 2018 and Jul 22, 2025 — classified as 105 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (105 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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device105
- Fluid/Blood Leak30
- Leak/Splash30
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient44
- Pain6
- Tissue Breakdown6
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETERS (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563332 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETERS (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563298 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETERS (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563296 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETER (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563295 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETER (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563281 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETER (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563275 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985955 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985951 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985948 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985946 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985910 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985907 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985906 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985904 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985902 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985901 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968122 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968121 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968118 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968117 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968116 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968114 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968112 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968111 ↗MalfunctionDec 13, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968109 ↗
Other Protector, Ostomy devices
- NATURA 404593Convatec, Purchasing Department · PROTECTOR, OSTOMY2,403 reports
- SUR-FIT NATURA 413182Convatec, Purchasing Department · PROTECTOR, OSTOMY1,202 reports
- SUR-FIT NATURA 413180Convatec, Purchasing Department · PROTECTOR, OSTOMY1,190 reports
- SUR-FIT NATURA 413179Convatec, Purchasing Department · PROTECTOR, OSTOMY1,178 reports
- SUR-FIT NATURA 413181Convatec, Purchasing Department · PROTECTOR, OSTOMY974 reports
- NATURA 411802Convatec, Purchasing Department · PROTECTOR, OSTOMY966 reports
- NATURA 404592Convatec, Purchasing Department · PROTECTOR, OSTOMY907 reports
- SUR-FIT NATURA 413183Convatec, Purchasing Department · PROTECTOR, OSTOMY773 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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