SUR-FIT NATURA 413184Recalls & 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 3/8" (35Mm.) · 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 skin barrier is a wafer worn around an ostomy opening to protect the skin. Its 153 reports mostly describe the wafer being placed in the wrong position, and most say no patient impact was reported. The reports include no deaths and 1 injury, and 152 are malfunctions. 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
- 153
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00768455106448), received between Nov 20, 2019 and Feb 25, 2022 — classified as 1 injury, 152 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (152 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 Device152
- Positioning Problem46
- Device Handling Problem1
Patient problems
- No Patient Involvement88
- No Consequences Or Impact To Patient63
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
- Skin Irritation1
- Tissue Breakdown1
- Ulcer1
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2022Device Handling Problem; Device Handling Problem
IT WAS REPORTED BY THE CONSUMER'S WIFE WHO PERFORMS HIS OSTOMY CARE THAT THE CONSUMER HAD USED THIS WAFER FOR OVER A YEAR. THE APPLIANCE WEAR-TIME WAS TWO TO THREE DAYS. IN (B)(6) 2021, CONSUMER DEVELOPED A SMALL PIMPLE JUST TO THE RIGHT OF THE STOMA UNDERNEATH THE WAFER MASS. THE WOUND ENLARGED TO 25 X 38 MM WITH TUNNELING. MINIMAL, SPOTTY BLEEDING OCCURRED WITH APPLIANCE CHANGES. NO STOOL LEAKAGE WAS REPORTED AT THAT TIME. CONSUMER FOLLOWED UP WITH SURGEON WHO ORDERED TOPICAL FLONASE AND FOR CONSUMER TO FOLLOW UP WITH DERMATOLOGIST AND LOCAL OSTOMY NURSE. SURGEON MADE THE DIAGNOSIS OF ULCER AND STATED, THESE THINGS SOMETIMES HAPPEN AND CAUSE OF WOUND WAS NOT SUGGESTED. NO OTHER DIAGNOSIS WAS MADE FROM DERMATOLOGIST. NEITHER DOCTOR OF MEDICINE (MD) NOR THE OSTOMY NURSE ADVISED CONSUMER TO DISCONTINUE USING CONVATEC'S APPLIANCE. LOCAL OSTOMY NURSE USED ALGINATE DRESSING FROM MIDWAY. THE END USER'S WIFE STATED THAT THE WOUND WAS NOW 1/4 INCH IN DIAMETER AND THERE WAS NO LONGER TUNNELING. SHE STATED THAT THE AREA WAS ALMOST COMPLETELY HEALED. THE END USER ALSO USES AN OSTOMY BELT AND REPORTS THAT IT WAS NOT WORN TOO TIGHTLY AND DOES NOT CAUSE DISCOMFORT. UPON RECEIPT OF PHOTOS, THE E
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Tissue Breakdown; Ulcer
MAUDE report 13597712 ↗MalfunctionMay 27, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090460 ↗MalfunctionMay 27, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090459 ↗MalfunctionMay 27, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090457 ↗MalfunctionMay 27, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090456 ↗MalfunctionMay 27, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090455 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090450 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090449 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090448 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090447 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090446 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090445 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090444 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090443 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090442 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090441 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090440 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090439 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090429 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090428 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090427 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090426 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090425 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090424 ↗MalfunctionMay 26, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10090423 ↗
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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