ESTEEM SYNERGY 405478Recalls & reported problems
Convatec, Purchasing Department · Esteem Synergy® Stomahesive® Skin Barrier With White Flexible Collar / Pre-Cut / 1 1/4" (32Mm) · Class 1
All models of ESTEEM SYNERGY (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00768455105106), received between Dec 15, 2018 and Dec 15, 2018 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (6 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 Device6
Patient problems
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2018Malposition 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 8167724 ↗MalfunctionDec 15, 2018Malposition 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 8167723 ↗MalfunctionDec 15, 2018Malposition 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 8167721 ↗MalfunctionDec 15, 2018Malposition 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 8167720 ↗MalfunctionDec 15, 2018Malposition 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 8167718 ↗MalfunctionDec 15, 2018Malposition 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 8167715 ↗
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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