SUR-FIT NATURA 125269Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Stomahesive® Flexible Pre-Cut 4" X 4" Wafer Tan 3/4 Stoma, Flange Size 1 3/4 · 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 pre-cut ostomy wafer is a skin barrier that attaches to a pouch over a stoma. The 27 reports describe the wafer sitting in the wrong position or not staying attached, with a few mentioning fluid or blood leaking, and no reports describe deaths or injuries. 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00768455101825), received between Mar 23, 2020 and Mar 30, 2022 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (27 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.
Most reported problems
Device problems
- Malposition of Device27
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948878 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948874 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948863 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948858 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948790 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948782 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948781 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948771 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948765 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948763 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948757 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948643 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948642 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948636 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948635 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948634 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948629 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948623 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948621 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948620 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948619 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948617 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948614 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948613 ↗MalfunctionMar 30, 2022Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE STARTER HOLE OF TWENTY FIVE WAFERS OUT OF THREE BOXES OF WAFERS WERE OFF-CENTERED. SHE WAS UNABLE TO USE ANY OF THE WAFERS SINCE THEY WOULD NOT ATTACH TO POUCH. AN ELECTRONIC MAIL WAS RECEIVED FROM RETAILER AND LOT NUMBER WAS CONFIRMED WITH CONSUMER. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13948612 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page