SUR-FIT NATURA 125274Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Stomahesive® Flexible Pre-Cut 4" X 4" Wafer Tan 1 3/8 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
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00768455101870), received between Feb 25, 2020 and Aug 9, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (6 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 Device6
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Malposition of Device; Malposition of Device
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19947514 ↗MalfunctionAug 9, 2024Malposition of Device; Malposition of Device
THE PATIENT'S WIFE REPORTED THAT THE STARTER HOLE WAS OFF CENTERED FOR TWO SKIN BARRIERS UPON OPENING. THE PRODUCT WAS NOT USED. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19947513 ↗MalfunctionFeb 25, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9749515 ↗MalfunctionFeb 25, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9749509 ↗MalfunctionFeb 25, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9749508 ↗MalfunctionFeb 25, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9749507 ↗
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.
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