SUR-FIT NATURA 413167Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Durahesive® Flexible Skin Barrier W/Flange (Overall Dimension 5" X 5" ) Tan, W/Tape Collar 2 1/4" (57Mm.) · Class 1
- 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 00768455106271), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
Patient problems
- Contact Dermatitis1
- Hemorrhage/Blood Loss/Bleeding1
- Necrosis1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER USING THE COMPANY'S KNOWN WAFER, DERMATITIS LESIONS HAD DEVELOPED ON AN OLD MALE PATIENT BELOW THE BARRIER JUST AROUND THE CIRCUMFERENCE OF THE ADHESIVE MATERIAL. THE END USER'S SOFT TISSUE WAS DISTRESSED AND THERE WAS TOTAL DEFACELLATION OF PERISTOMAL SKIN IN THE SAME WAY NECROSIS OF THE STOMA WAS OBSERVED, WITH LOSS OF EPIDERMIS WITH EXPOSURE OF DERMIS WHICH WAS DARK PURPLE IN COLOR OCCURRED. IT WAS DUE TO COMPONENTS OF THE MEDICAL DEVICE, WHICH WAS FOUND DURING THE FIRST 24 HOURS OF POST-SURGERY. THE PATIENT USED THE DEVICE FOR LESS THAN ONE DAY. THE DEVICE WAS REMOVED, AND IT WAS IMMEDIATELY INFORMED TO A SPECIALIST SURGEON ABOUT THE ISSUE. ASSESSMENT FOR BLEEDING STOMA WAS PERFORMED AND THE PATIENT WAS TAKEN TO A SURGERY FOR NEW COLOSTOMY REMODELING AND THE SKIN NECROSIS WAS FURTHER COMPROMISED. FURTHER, INSTITUTIONAL WOUND CARE PROFESSIONAL STARTED ENZYMATIC DEBRIDEMENT. FOR SURGICAL CLEANING, CHLORHEXIDINE SOAP AND SOLUTION WAS USED. DURING THE HOSPITALIZATION, HE HAD NOT MANIFESTED ANY ALLERGIC EVENT. HE HAD BEEN DEBRIDING WITH COMPANY'S DRESSING AND HAD NOT PRESENTED ANY ALLERGIC REACTION AT THAT MOMENT. PHOTOGRAPHS DEPICTING THE ISSUE AND PATIEN
Patient problems: Contact Dermatitis; Hemorrhage/Blood Loss/Bleeding; Necrosis; Tissue Breakdown
MAUDE report 16476034 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.