SUR-FIT NATURA 413182Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Durahesive® Skin Barrier W/Convex-It® With 45Mm.-(1 3/4" ) Flange, W/Tape Collar-Pre-Cut 1 1/8" (28Mm.) · Class 1
All models of SUR-FIT NATURA (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec SUR-FIT Natura ostomy skin barrier has 1,202 adverse event reports, with no deaths and no injuries. The reports describe the pre-cut opening in the wafer being off center, and some describe fluid leaking. No recalls name this device. Reports in the last 12 months (44) are more than in the 12 months before (28).
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
- 1,202
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,202 adverse event reports that list this exact device (DI 00768455106424), received between Dec 28, 2018 and Feb 26, 2026 — classified as 1,202 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (1,202 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 Device1,202
- Fluid/Blood Leak30
- Positioning Problem3
Patient problems
- No Patient Involvement489
- No Consequences Or Impact To Patient355
- No Clinical Signs, Symptoms or Conditions338
- Discomfort10
- Rash10
- Skin Irritation10
Recent adverse event reports
The 25 most recent of 1,202 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453499 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453497 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453496 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453494 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452976 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452974 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452967 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452966 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452965 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452964 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452962 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452961 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452863 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452859 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452856 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452855 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452854 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452853 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452852 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452851 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452850 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452849 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452848 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452846 ↗MalfunctionFeb 26, 2026Malposition of Device
THE END USER REPORTED THAT UPON VISUAL INSPECTION THIRTY OUT OF FOUR MARKET UNITS WITH THE SAME LOT NUMBER, PRECUT OPENING WAFERS WERE OFF CENTERED. HE STATED THAT SEVERAL OF THEM WERE FAR OFF TO ONE SIDE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452844 ↗
Other PROTECTOR, OSTOMY devices
- NATURA 404593Convatec, Purchasing Department · PROTECTOR, OSTOMY2,403 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
- NATURA 404594Convatec, Purchasing Department · PROTECTOR, OSTOMY330 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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