SUR-FIT NATURA 125277Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Stomahesive® Flexible Pre-Cut 5" X 5" Wafer Tan 1 3/4 Stoma, Flange Size 2 1/4 · Class 1
All models of SUR-FIT NATURA (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455101900), received between Dec 20, 2021 and Dec 20, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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
- Device Handling Problem1
Patient problems
- Dizziness1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2021Device Handling Problem; Device Handling Problem
THE END USER REPORTED THAT HE EXPERIENCED BLEEDING WHERE THE STOMA MET THE SKIN. HE STATED THAT IT FILLED HIS POUCH TO ONE-THIRD FULL OF BLOOD BUT UNABLE TO STATE IF IT WAS BRIGHT RED OR NOT. HE WENT TO THE EMERGENCY BECAUSE HE BECAME DIZZY. HIS USUAL WEAR TIME WAS TWO TO THREE DAYS AND DID NOT CHANGE. HE FURTHER STATED THAT THE HEALTH PROFESSIONAL CAUTERIZED IT AT THE EMERGENCY. HE CLEANED HIS SKIN WITH WARM WATER AND ALSO CUT THE PRECUT STARTER HOLE TO OVAL SHAPE FOR HIS STOMA SHAPE. HE DISCONTINUED THE USE OF COMPANY PRODUCT AND WENT BACK TO USING PRODUCT OF ANOTHER BRAND. AFTER USING SWITCHING TO ANOTHER PRODUCT THE ISSUE RESOLVED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Dizziness; Hemorrhage/Blood Loss/Bleeding
MAUDE report 13041879 ↗
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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