SUR-FIT NATURA 413181Recalls & 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 1" (25Mm.) · 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 ostomy skin barrier is a flange that sits around a stoma. Most of its 974 reports describe the barrier being in the wrong position, and some describe leaks, skin breakdown and bleeding. The reports mention no deaths and 11 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
- 974
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 974 adverse event reports that list this exact device (DI 00768455106417), received between Dec 7, 2018 and May 30, 2023 — classified as 11 injuries, 963 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (949 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 Device949
- Positioning Problem70
- Fluid/Blood Leak35
- Material Erosion15
- Adverse Event Without Identified Device or Use Problem10
Patient problems
- No Consequences Or Impact To Patient449
- No Patient Involvement354
- Hemorrhage/Blood Loss/Bleeding75
- Tissue Breakdown75
- No Clinical Signs, Symptoms or Conditions49
- Laceration(s)46
- Skin Irritation25
- Blood Loss12
Recent adverse event reports
The 25 most recent of 974 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018116 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018115 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018114 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018094 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018093 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018092 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018091 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018089 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018088 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018074 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018073 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018070 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018024 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018023 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018022 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018021 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17018020 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017979 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017978 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017977 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017976 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017975 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017974 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017937 ↗MalfunctionMay 30, 2023Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 17017936 ↗
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
- 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 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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