SUR-FIT NATURA 413419Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Acrylic Flexible Collar [70Mm (2 3/4") - X-Large] · Class 1
All models of SUR-FIT NATURA (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Convatec SUR-FIT Natura moldable ostomy skin barrier, a wafer worn around a stoma. The 62 reports mostly describe the barrier being misshapen or the starter hole sitting off center so it does not fit or stay in place, and one describes skin irritation with redness and breakdown under the tape collar. There are no deaths, 1 injury, and 61 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 62
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00768455123933), received between Feb 28, 2019 and Feb 18, 2025 — classified as 1 injury, 61 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (61 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device61
- Positioning Problem13
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Consequences Or Impact To Patient58
- No Clinical Signs, Symptoms or Conditions3
- Cellulitis1
- Erythema1
- Hemorrhage/Blood Loss/Bleeding1
- Itching Sensation1
- Skin Inflammation/ Irritation1
- Tissue Breakdown1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE WAS OFF CENTERED PRIOR TO USE. THE PRODUCT WAS NOT USED BY PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405090 ↗MalfunctionDec 1, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT WAFERS HAD STARTER HOLE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15892349 ↗MalfunctionDec 1, 2022Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15892348 ↗InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CONSUMER REPORTED TO SPECIALIST ON 31ST MARCH 2022 THAT HE EXPERIENCED SKIN IRRITATION AROUND TAPE AREA AFTER USING WAFER. OUTBOUND CALL WAS MADE, HOWEVER, NO OTHER INFORMATION WAS RECEIVED. ON (B)(6) 2022, CONSUMER CALLED BACK AND REPORTED THAT HE STARTED TO HAVE REDNESS ON THE SKIN WITH SKIN BREAKDOWN AND BLEEDING UNDER THE TAPE COLLAR APPROXIMATELY TWO WEEKS AGO. THE REDNESS WAS ONLY IN ONE AREA UNDER THE TAPE COLLAR ON THE SIDE UNDER THE STOMA. HE ALSO HAD SENSATIONS OF ITCHING. HE WENT TO SEE HIS DOCTOR OF MEDICINE (MD) WHO FELT THAT HE HAD DEVELOPED CELLULITIS UNDER THE TAPE COLLAR AND PRESCRIBED ORAL ANTIBIOTICS. HE DID NOT KNOW ABOUT ANTIBIOTIC PRESCRIBED BY DOCTOR. HE ALSO PRESCRIBED NEOSPORIN TO BE APPLIED TO THE AREA WITH EACH WAFER CHANGE. HE COMPLETED THE COURSE OF ANTIBIOTICS SEVERAL DAYS AGO. THE CONSUMER HAD BEEN USING THIS WAFER FOR AT LEAST SIX MONTHS WITHOUT ANY DIFFICULTIES WITH A WEAR TIME OF SEVEN DAYS. HE REPORTED A SKIN CARE ROUTINE OF USING BABY SHAMPOO IN THE SHOWER TO CLEAN THE PERISTOMAL SKIN. HE ALSO USES ADHESIVE REMOVER WIPES AND SKIN PROTECTANT WIPES. THE CUSTOMER WAS ADVISED TO NOTIFY HIS MD ABOUT THE SKIN CONDITION THAT HAD NOT IMPROVED AND HE
Patient problems: Cellulitis; Erythema; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Skin Inflammation/ Irritation; Tissue Breakdown
MAUDE report 14191882 ↗MalfunctionSep 28, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10592302 ↗MalfunctionSep 28, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10592301 ↗MalfunctionSep 28, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10592298 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499204 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499203 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499202 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499200 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499199 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499198 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499181 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499179 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499178 ↗MalfunctionSep 7, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499177 ↗MalfunctionDec 13, 2019Malposition 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 9464949 ↗MalfunctionDec 13, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9464930 ↗MalfunctionDec 13, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9464929 ↗MalfunctionDec 13, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9464928 ↗MalfunctionDec 13, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9464927 ↗MalfunctionNov 15, 2019Malposition 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 9327760 ↗MalfunctionNov 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9327732 ↗MalfunctionNov 15, 2019Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9327729 ↗
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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