NATURA 404593Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Durahesive® Moldable Convex Skin Barrier With 45Mm.-(1 3/4" ) Flange, Mold -To-Fit Opening-Medium 7/8" -1 1/4" · Class 1
Quick summary
This Convatec SUR-FIT Natura is a moldable ostomy skin barrier worn around the stoma. Most of its 2,403 reports describe the barrier sitting in the wrong position, and some describe leaks or a base plate too stiff to mold. They mention 2 injuries and no deaths, and 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
- 2,403
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,403 adverse event reports that list this exact device (DI 00768455104536), received between Nov 13, 2018 and Aug 11, 2026 — classified as 2 injuries, 2,401 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (2,383 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device2,383
- Positioning Problem204
- Fluid/Blood Leak112
- Material Disintegration31
- Material Erosion11
- Material Discolored3
- Material Too Rigid or Stiff3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Consequences Or Impact To Patient1,905
- No Patient Involvement338
- No Clinical Signs, Symptoms or Conditions98
- Erythema33
- Tissue Breakdown32
- Skin Irritation20
- Anxiety6
- Distress6
Recent adverse event reports
The 25 most recent of 2,403 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206174 ↗MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206173 ↗MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206172 ↗MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206130 ↗MalfunctionFeb 20, 2026Material Discolored; Material Too Rigid or Stiff
THE NURSE PRACTITIONER REPORTED THAT THE BASE PLATE WAS VERY RIGID, COULD NOT BE MOLDED, AND APPEARED ALMOST WHITE IN COLOR. THE PRODUCT WAS USED ON PATIENT; HOWEVER, THE DURATION OF USE WAS UNKNOWN. NO PHOTO WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399457 ↗MalfunctionFeb 20, 2026Material Discolored; Material Too Rigid or Stiff
THE NURSE PRACTITIONER REPORTED THAT THE BASE PLATE WAS VERY RIGID, COULD NOT BE MOLDED, AND APPEARED ALMOST WHITE IN COLOR. THE PRODUCT WAS USED ON PATIENT; HOWEVER, THE DURATION OF USE WAS UNKNOWN. NO PHOTO WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399455 ↗MalfunctionFeb 20, 2026Material Discolored; Material Too Rigid or Stiff
THE NURSE PRACTITIONER REPORTED THAT THE BASE PLATE WAS VERY RIGID, COULD NOT BE MOLDED, AND APPEARED ALMOST WHITE IN COLOR. THE PRODUCT WAS USED ON PATIENT; HOWEVER, THE DURATION OF USE WAS UNKNOWN. NO PHOTO WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399452 ↗MalfunctionMar 27, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
THE DISTRIBUTOR REPORTED THAT FOUR WAFERS FROM ONE MARKET UNIT (MU) HAD OFF-CENTERED STARTER HOLES. TWO WERE USED AND TWO WERE NOT USED. THE END USER REPORTED THAT THE OFF-CENTERED HOLES ON THE WAFERS WERE OUT-OF-BOX FAILURES. HE TRIED TO USE TWO BUT EXPERIENCED LEAKAGE BECAUSE OF THE DEFECT. HE DECIDED NOT TO USE THE OTHER TWO WITH OFF-CENTERED STARTER HOLES. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707328 ↗MalfunctionMar 27, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
THE DISTRIBUTOR REPORTED THAT FOUR WAFERS FROM ONE MARKET UNIT (MU) HAD OFF-CENTERED STARTER HOLES. TWO WERE USED AND TWO WERE NOT USED. THE END USER REPORTED THAT THE OFF-CENTERED HOLES ON THE WAFERS WERE OUT-OF-BOX FAILURES. HE TRIED TO USE TWO BUT EXPERIENCED LEAKAGE BECAUSE OF THE DEFECT. HE DECIDED NOT TO USE THE OTHER TWO WITH OFF-CENTERED STARTER HOLES. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707326 ↗MalfunctionMar 27, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
THE DISTRIBUTOR REPORTED THAT FOUR WAFERS FROM ONE MARKET UNIT (MU) HAD OFF-CENTERED STARTER HOLES. TWO WERE USED AND TWO WERE NOT USED. THE END USER REPORTED THAT THE OFF-CENTERED HOLES ON THE WAFERS WERE OUT-OF-BOX FAILURES. HE TRIED TO USE TWO BUT EXPERIENCED LEAKAGE BECAUSE OF THE DEFECT. HE DECIDED NOT TO USE THE OTHER TWO WITH OFF-CENTERED STARTER HOLES. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707325 ↗MalfunctionMar 27, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
THE DISTRIBUTOR REPORTED THAT FOUR WAFERS FROM ONE MARKET UNIT (MU) HAD OFF-CENTERED STARTER HOLES. TWO WERE USED AND TWO WERE NOT USED. THE END USER REPORTED THAT THE OFF-CENTERED HOLES ON THE WAFERS WERE OUT-OF-BOX FAILURES. HE TRIED TO USE TWO BUT EXPERIENCED LEAKAGE BECAUSE OF THE DEFECT. HE DECIDED NOT TO USE THE OTHER TWO WITH OFF-CENTERED STARTER HOLES. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707324 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658578 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658576 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
THE END USER REPORTED THAT PLASTIC WAS EXPOSED AT EDGE UNDER MASS. ALSO, IT WAS STATED THAT SOME MASS APPEARED TO BE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658555 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658542 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
THE END USER REPORTED THAT PLASTIC WAS EXPOSED AT EDGE UNDER MASS. ALSO, IT WAS STATED THAT SOME MASS APPEARED TO BE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658538 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
THE END USER REPORTED THAT PLASTIC WAS EXPOSED AT EDGE UNDER MASS. ALSO, IT WAS STATED THAT SOME MASS APPEARED TO BE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658439 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
THE END USER REPORTED THAT PLASTIC WAS EXPOSED AT EDGE UNDER MASS. ALSO, IT WAS STATED THAT SOME MASS APPEARED TO BE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658085 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
THE END USER REPORTED THAT PLASTIC WAS EXPOSED AT EDGE UNDER MASS. ALSO, IT WAS STATED THAT SOME MASS APPEARED TO BE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19658083 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
THE END USER REPORTED THAT PLASTIC WAS EXPOSED AT EDGE UNDER MASS. ALSO, IT WAS STATED THAT SOME MASS APPEARED TO BE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657985 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657982 ↗MalfunctionJul 2, 2024Material Erosion; Material Erosion
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657981 ↗MalfunctionJan 6, 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 16111173 ↗MalfunctionJan 6, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED BY END USER THAT THE CENTER HOLE OF FOUR PRODUCTS WAS OFF CENTERED WHICH CAUSED INCONSISTENT VISCOSITY WIDTH AROUND DURING USE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16111172 ↗MalfunctionJan 6, 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 16111171 ↗
Other PROTECTOR, OSTOMY devices
- 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
- NATURA 404594Convatec, Purchasing Department · PROTECTOR, OSTOMY330 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.