SUR-FIT NATURA 413161Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Durahesive® Flexible Skin Barrier W/Flange (Overall Dimension 4" X 4" ) Wht W/Tape Collar 1 3/4" (45Mm.) · Class 1
All models of SUR-FIT NATURA (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455106219), received between Sep 24, 2021 and Sep 24, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
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
- Complete Blockage1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2021Complete Blockage; Material Protrusion/Extrusion; Complete Blockage; Material Protrusion/Extrusion
THE END USER STATED THAT SHE TRIED ONE WAFER AND IT SWELLED UP AND COVERED HER STOMA. SHE BELIEVED THAT THIS CAUSED AN OBSTRUCTION, PREVENTING EFFLUENT FROM ENTERING THE POUCH FOR OVER ONE HOUR. SHE ALSO REPORTED THAT ONCE THE WAFER WAS REMOVED, SHE HAD OUTPUT. IT WAS ADVISED THAT IF THE STOMA DOES NOT PROTRUDE WELL, IT COULD COVER THE STOMA. REPORTEDLY, CONVEXITY WAS SUGGESTED BUT SHE REFUSED. SHE ALSO STATED THAT SHE TRIED 413161 BEFORE AND THIS DID NOT HAPPEN BUT THAT THE WAFERS SHE RECEIVED AND WERE LABELED 413161 LOOKED DIFFERENT. IT WAS ALSO REPORTED THAT THE PATIENT¿S EFFLUENT VARIES FROM WATERY TO LOOSE CONSISTENCY. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12525074 ↗
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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