ESTEEM SYNERGY 411659Recalls & reported problems
Convatec, Purchasing Department · Esteem Synergy® Stomahesive® Moldable Skin Barrier - Large, 61 (33-45Mm Stoma Range) · Class 1
All models of ESTEEM SYNERGY (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Esteem Synergy moldable ostomy skin barrier is a wafer that fits around a stoma. The 53 reports all describe the same molding issue: the starter hole, the opening meant to be stretched and centered over the stoma, sitting off center in the product itself. None describe deaths or injuries, and 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
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00768455117352), received between Dec 15, 2018 and Apr 30, 2020 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (53 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 Device53
Patient problems
- No Consequences Or Impact To Patient37
- No Patient Involvement16
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012699 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012698 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012697 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012696 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012695 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012694 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012693 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012692 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012691 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012690 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012689 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012688 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012687 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012686 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012685 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012684 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012683 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012682 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012676 ↗MalfunctionApr 30, 2020Malposition of Device; Malposition of Device
ON (B)(6) 2020, THE END USER INSPECTED 20 UNUSED WAFERS FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER AND CONFIRMED THAT THE STARTER HOLE WAS OFF CENTERED IN ALL OF THE MOLDABLE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012675 ↗MalfunctionFeb 7, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THERE WERE 5 UNUSED WAFERS IN BOX WITH STARTER HOLE OFF CENTERED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9680521 ↗MalfunctionFeb 7, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THERE WERE 5 UNUSED WAFERS IN BOX WITH STARTER HOLE OFF CENTERED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9680520 ↗MalfunctionFeb 7, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THERE WERE 5 UNUSED WAFERS IN BOX WITH STARTER HOLE OFF CENTERED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9680519 ↗MalfunctionFeb 7, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THERE WERE 5 UNUSED WAFERS IN BOX WITH STARTER HOLE OFF CENTERED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9680516 ↗MalfunctionFeb 7, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THERE WERE 5 UNUSED WAFERS IN BOX WITH STARTER HOLE OFF CENTERED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9680515 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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