SUR-FIT NATURA 401513Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00768455103355), received between Feb 6, 2023 and Feb 6, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (5 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
- Sharp Edges5
Patient problems
- Skin Inflammation/ Irritation5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2023Sharp Edges; Sharp Edges
THE COMPLAINT WAS RECEIVED BY THE RETAILER WHO FURTHER RECEIVED INFORMATION FROM THE END USER ABOUT POUCH OUTLINE NOT SMOOTH (REDUNDANT FIBER) AND HAD ROUGH OR SHARP EDGE WHICH CAUSED SKIN IRRITATION. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16302419 ↗MalfunctionFeb 6, 2023Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16302405 ↗MalfunctionFeb 6, 2023Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16302403 ↗MalfunctionFeb 6, 2023Sharp Edges; Sharp Edges
THE COMPLAINT WAS RECEIVED BY THE RETAILER WHO FURTHER RECEIVED INFORMATION FROM THE END USER ABOUT POUCH OUTLINE NOT SMOOTH (REDUNDANT FIBER) AND HAD ROUGH OR SHARP EDGE WHICH CAUSED SKIN IRRITATION. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16302392 ↗MalfunctionFeb 6, 2023Sharp Edges; Sharp Edges
THE COMPLAINT WAS RECEIVED BY THE RETAILER WHO FURTHER RECEIVED INFORMATION FROM THE END USER ABOUT POUCH OUTLINE NOT SMOOTH (REDUNDANT FIBER) AND HAD ROUGH OR SHARP EDGE WHICH CAUSED SKIN IRRITATION. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16302390 ↗
Other Bag, drainage, with adhesive, ostomy devices
- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423657Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ACTIVELIFE 022767Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy60 reports
- ESTEEM+ 416740Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy55 reports
- ACTIVELIFE 022765Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy53 reports
- ESTEEM 423665Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423646Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
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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