ESTEEM SYNERGY 409270Recalls & reported problems
Convatec, Purchasing Department · Esteem Synergy® Durahesive® Moldable Convex Skin Barrier With White Flexible Collar / Large · Class 1
All models of ESTEEM SYNERGY (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00768455105250), received between Oct 26, 2018 and May 11, 2020 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (13 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
- Malposition of Device13
Patient problems
- No Consequences Or Impact To Patient13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN 4 OUT OF 10 WAFERS. THE BOX WAS NEWLY OPENED SO THE PRODUCTS HAD NOT BEEN USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10042275 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN 4 OUT OF 10 WAFERS. THE BOX WAS NEWLY OPENED SO THE PRODUCTS HAD NOT BEEN USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10042274 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN 4 OUT OF 10 WAFERS. THE BOX WAS NEWLY OPENED SO THE PRODUCTS HAD NOT BEEN USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10042273 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN 4 OUT OF 10 WAFERS. THE BOX WAS NEWLY OPENED SO THE PRODUCTS HAD NOT BEEN USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10042272 ↗MalfunctionMay 11, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTERED IN 1 OUT OF 10 WAFERS. THE BOX WAS NEWLY OPENED SO THE PRODUCTS HAD NOT BEEN USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10042084 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008700 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008696 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008695 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008672 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008667 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008666 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008665 ↗MalfunctionOct 26, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED EIGHT WAFERS WERE MADE OFF CENTER, SO MUCH THAT THE END USER COULD NOT USE IT. NO PHOTO WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8008662 ↗
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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