NATURA 411804Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [57Mm (2 1/4" ) - Large] · Class 1
All models of NATURA (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec SUR-FIT Natura skin barrier is a moldable ostomy wafer. Reports most often describe starter holes that are off center, with some mentioning material that is too stiff or breaks down. Most describe no impact on patients. The database holds 245 reports, all malfunctions, with no deaths and no injuries. No recalls name this device, and reports appeared over the last year (10) after none in the year before (0).
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
- 245
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 245 adverse event reports that list this exact device (DI 00768455105984), received between Jan 2, 2019 and Nov 4, 2025 — classified as 245 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (238 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device238
- Material Disintegration7
- Material Too Rigid or Stiff7
- Positioning Problem7
Patient problems
- No Consequences Or Impact To Patient160
- No Clinical Signs, Symptoms or Conditions55
- No Patient Involvement30
Recent adverse event reports
The 25 most recent of 245 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT TEN WAFER STARTER HOLES WERE OFF CENTERED. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461790 ↗MalfunctionNov 4, 2025Malposition 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 23461788 ↗MalfunctionNov 4, 2025Malposition 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 23461758 ↗MalfunctionNov 4, 2025Malposition 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 23461757 ↗MalfunctionNov 4, 2025Malposition 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 23461755 ↗MalfunctionNov 4, 2025Malposition 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 23461754 ↗MalfunctionNov 4, 2025Malposition 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 23461753 ↗MalfunctionNov 4, 2025Malposition 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 23461750 ↗MalfunctionNov 4, 2025Malposition 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 23461749 ↗MalfunctionNov 4, 2025Malposition 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 23461369 ↗MalfunctionAug 10, 2023Malposition 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 17496522 ↗MalfunctionMay 9, 2023Malposition 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 16894340 ↗MalfunctionMay 9, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF EIGHT MOLDABLE WAFERS WERE SIGNIFICANTLY OFF CENTERED FROM ONE MARKET UNIT (MU) FOR KNOWN LOT. HE FELT THAT THIS MADE THE WAFER UNUSABLE. IT WAS OBSERVED PRIOR TO USE AND THE END USER DID NOT USED THE PRODUCTS. ALSO, THE END USER REPORTED THAT THE ISSUE WAS FIRSTLY NOTICED APPROXIMATELY FIVE MONTHS AGO. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894339 ↗MalfunctionMay 9, 2023Malposition 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 16894337 ↗MalfunctionMay 9, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF EIGHT MOLDABLE WAFERS WERE SIGNIFICANTLY OFF CENTERED FROM ONE MARKET UNIT (MU) FOR KNOWN LOT. HE FELT THAT THIS MADE THE WAFER UNUSABLE. IT WAS OBSERVED PRIOR TO USE AND THE END USER DID NOT USED THE PRODUCTS. ALSO, THE END USER REPORTED THAT THE ISSUE WAS FIRSTLY NOTICED APPROXIMATELY FIVE MONTHS AGO. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894336 ↗MalfunctionMay 9, 2023Malposition 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 16894335 ↗MalfunctionMay 9, 2023Malposition 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 16894333 ↗MalfunctionMay 9, 2023Malposition 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 16894331 ↗MalfunctionMay 9, 2023Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF EIGHT MOLDABLE WAFERS WERE SIGNIFICANTLY OFF CENTERED FROM ONE MARKET UNIT (MU) FOR KNOWN LOT. HE FELT THAT THIS MADE THE WAFER UNUSABLE. IT WAS OBSERVED PRIOR TO USE AND THE END USER DID NOT USED THE PRODUCTS. ALSO, THE END USER REPORTED THAT THE ISSUE WAS FIRSTLY NOTICED APPROXIMATELY FIVE MONTHS AGO. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16894330 ↗MalfunctionNov 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742276 ↗MalfunctionNov 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742273 ↗MalfunctionNov 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742272 ↗MalfunctionNov 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742271 ↗MalfunctionNov 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742269 ↗MalfunctionNov 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE STARTER HOLE OF THIRTEEN SKIN BARRIERS WAS SLIGHTLY OFF CENTERED. THE PRODUCT WAS NOT USED BY END USER. THERE WAS NO HARM REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742268 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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