SUR-FIT NATURA 413156Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Durahesive® Skin Barrier W/Flange (Overall Dimension 4" X4" ) W/O Tape Collar 2 1/4" (57Mm.) · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455106172), received between Sep 16, 2021 and Sep 16, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erythema1
- Fluid Discharge1
- Necrosis1
- Skin Inflammation/ Irritation1
- Tissue Breakdown1
- Ulcer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE END USER'S WIFE REPORTED THAT THE WAFER WAS WORKING WELL AND LASTED ALMOST A WEEK. HOWEVER, SHE ALSO REPORTED RED SORE UNDER MASS APPROXIMATELY 0.5-1 INCH AWAY FROM THE STOMA AT THE 7-8 O'CLOCK POSITION. SHE STATED THAT IT WAS APPROXIMATELY THE SIZE OF A SILVER DOLLAR AND WAS RED WITH A DIME-SIZED BLACK CENTER. THE AREA WAS DRAINING. IT STARTED APPROXIMATELY 1 WEEK AGO WITH THE REDNESS AREA AND DRAINAGE BUT SHE FIRST NOTED THE BLACK AREA ON THE DAY OF THIS REPORT. SHE WAS USING STOMAHESIVE POWDER AND AN UNKNOWN BRAND BARRIER WIPE AS WELL AS EAKIN. SHE WAS NOT ALLEGING THAT THE PRODUCT CAUSED THE SORE. SHE WAS UNSURE OF THE CAUSE. THE END USER'S WIFE HAD CONTACTED THE PHYSICIAN BUT HAD NOT YET RECEIVED A RESPONSE BUT STATED THAT SHE WILL DO SO AGAIN ON THE DAY OF THIS REPORT AND THE END USER CONTINUED TO USE THE PRODUCT.
Patient problems: Erythema; Fluid Discharge; Necrosis; Skin Inflammation/ Irritation; Tissue Breakdown; Ulcer
MAUDE report 12479759 ↗
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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