SUR-FIT NATURA 413180Recalls & 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 7/8" (22Mm.) · Class 1
Quick summary
This Convatec SUR-FIT Natura skin barrier is a wafer that sticks around an ostomy opening on the skin. Most of its 1,190 reports describe the pre-cut opening being off center, and others describe leaks and skin problems such as tissue damage and irritation. The reports include 1 injury and no deaths. 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
- 1,190
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,190 adverse event reports that list this exact device (DI 00768455106400), received between Oct 30, 2018 and Sep 2, 2025 — classified as 1 injury, 1,189 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (1,190 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 Device1,190
- Fluid/Blood Leak140
- Positioning Problem127
- Device Damaged Prior to Use3
Patient problems
- No Consequences Or Impact To Patient573
- No Patient Involvement441
- Tissue Damage131
- Skin Irritation90
- Itching Sensation30
- No Clinical Signs, Symptoms or Conditions14
- Blood Loss1
- Pain1
Recent adverse event reports
The 25 most recent of 1,190 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Device Damaged Prior to Use; Malposition of Device; Device Damaged Prior to Use; Malposition of Device
THE END USER REPORTED THAT THREE WAFERS IN THE BOX HAD PRE-CUT STARTER HOLES OFF CENTERED PRIOR TO USE. HE STATED THAT THIS MADE THE PRODUCT UNUSABLE. USUAL WEAR TIME WAS TWO DAYS NO PHOTO WAS AVAILABLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931973 ↗MalfunctionSep 2, 2025Device Damaged Prior to Use; Malposition of Device; Device Damaged Prior to Use; Malposition of Device
THE END USER REPORTED THAT THREE WAFERS IN THE BOX HAD PRE-CUT STARTER HOLES OFF CENTERED PRIOR TO USE. HE STATED THAT THIS MADE THE PRODUCT UNUSABLE. USUAL WEAR TIME WAS TWO DAYS; NO PHOTO WAS AVAILABLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931946 ↗MalfunctionSep 2, 2025Device Damaged Prior to Use; Malposition of Device; Device Damaged Prior to Use; Malposition of Device
THE END USER REPORTED THAT THREE WAFERS IN THE BOX HAD PRE-CUT STARTER HOLES OFF CENTERED PRIOR TO USE. HE STATED THAT THIS MADE THE PRODUCT UNUSABLE. USUAL WEAR TIME WAS TWO DAYS NO PHOTO WAS AVAILABLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931885 ↗MalfunctionDec 26, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED THE RING OF POUCH IS NOT LOCATED IN THE MIDDLE OF 63 WAFERS. PER THE PHOTOS RECEIVED, THE STARTER HOLE IS OFF CENTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18391455 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137530 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137528 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137527 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137526 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137525 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137511 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137510 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THIS EMDR IS CREATED FOR AN UNKNOWN QUANTITY OF WAFERS FROM THE MARKET UNIT BOX. THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137507 ↗MalfunctionAug 1, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT WAFERS HAD AN OFF CENTERED STOMA OPENING. SHE HAD DISCARDED THE PRODUCT. SHE DID NOT REMEMBER THE EXACT COUNT AND DID NOT HAVE THE LOT NUMBER. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137501 ↗MalfunctionJun 22, 2022Malposition of Device; Malposition of Device
THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF WAFERS FROM UNKNOWN NUMBER OF MARKET UNITS. THE END USER REPORTED THAT SOMETIMES THE WAFER HAD AN OFF CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED ON PATIENT. THE PRODUCTS WERE DISCARDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14768095 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222811 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222810 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222806 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222805 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222802 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222772 ↗MalfunctionJul 2, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10222770 ↗MalfunctionMay 28, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT 40 OUT OF 90 WAFERS FROM A TOTAL OF 9 MARKET UNITS HAD OFF CENTERED STARTER HOLES. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10095006 ↗MalfunctionMay 28, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT 40 OUT OF 90 WAFERS FROM A TOTAL OF 9 MARKET UNITS HAD OFF CENTERED STARTER HOLES. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10095004 ↗MalfunctionMay 28, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT 40 OUT OF 90 WAFERS FROM A TOTAL OF 9 MARKET UNITS HAD OFF CENTERED STARTER HOLES. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10095003 ↗MalfunctionMay 28, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT 40 OUT OF 90 WAFERS FROM A TOTAL OF 9 MARKET UNITS HAD OFF CENTERED STARTER HOLES. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10095002 ↗
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 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.