SUR-FIT NATURA 413160Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Durahesive® Flexible Skin Barrier W/Flange (Overall Dimension 4" X 4" ) Wht W/Tape Collar 1 1/2" (38Mm.) · 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 00768455106202), received between Feb 15, 2022 and Feb 15, 2022 — 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
- Bacterial Infection1
- Erythema1
- Itching Sensation1
- Peeling1
- Skin Infection1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE END USER STATED THAT PERISTOMAL SKIN UNDER THE ENTIRE TAPE COLLAR WAS RED, WITH A "SUNBURN" APPEARANCE AND IT WAS ITCHY, WEEPY, AND PEELING. THE ISSUE STARTED THREE MONTHS AGO UNDER THE TAPE COLLAR UNDER THE POUCH AND WAS UNDER THE ENTIRE TAPE COLLAR NOW. SHE HAD BEEN USING THIS PRODUCT FOR MANY YEARS WITHOUT ISSUE. SHE SAW A DERMATOLOGIST WHO DID A SKIN CULTURE SWAB TO THE AREA AROUND THE WAFER BUT NOT TO THE AREA UNDER THE TAPE COLLAR. THE RESULTS SHOWED BACTERIA FOR WHICH SHE RECEIVED TREATMENT WITH A PRESCRIPTION ORAL ANTI-BACTERIAL MEDICATION. THE DERMATOLOGIST REFERRED HER TO A NURSE. THE END USER THEN SAW A WOUND NURSE WHO PRESCRIBED TRIAMCINOLONE SPRAY EVERY THREE DAYS WITH APPLIANCE CHANGE. THAT HAD PROVIDED SOME IMPROVEMENT AND THE AREA WAS NO LONGER WEEPY. SHE HAS ALSO TRIALED AN ANTI-FUNGAL POWDER THAT SHE HAD ON HAND FOR UNRELATED ISSUE. THE TRIAMCINOLONE SPRAY WORKED BETTER. THE END USER'S STOMA MEASURED TWENTY-EIGHT MM. SHE CLEANSED WITH AN ANTI-BACTERIAL SOAP AND DID NOT USE PROTECTIVE BARRIER WIPES OR ADHESIVE REMOVER WIPES. NO PHOTO IS AVAILABLE AT THIS TIME AND SHE CONTINUED USING THE PRODUCT.
Patient problems: Bacterial Infection; Erythema; Itching Sensation; Peeling; Skin Infection; Tissue Breakdown
MAUDE report 13533668 ↗
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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