SUR-FIT NATURA 413178Recalls & 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 5/8" (16Mm.) · 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 is a skin barrier for an ostomy bag. Most of the 80 reports describe the barrier being misplaced or having misshapen openings, and one describes bleeding from a sore that needed cauterizing. The reports include 1 injury and no deaths. 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
- 80
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00768455106387), received between Nov 27, 2019 and Jun 30, 2022 — classified as 1 injury, 79 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (79 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 Device79
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Consequences Or Impact To Patient79
- Hemorrhage/Blood Loss/Bleeding1
- Tissue Breakdown1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF WAFERS FROM AN UNKNOWN NUMBER OF BOXES. THE END USER REPORTED BLEEDING FROM THE CONSTANT SORE STARTED IN (B)(6) 2021 AND THEN AGAIN IN (B)(6) 2021 WHEN HE RECEIVED CAUTERIZATION TO THE AFFECTED AREA. IN (B)(6) 2022, THE SORE STARTED TO BLEED AGAIN AND WAS CAUTERIZED BY HIS DOCTOR TWO WEEKS AGO. CONSUMER HAD THREE EPISODES OF BLEEDING IN ONE WEEK SINCE THE CAUTERIZATION. THE FIRST EPISODE OF BLEEDING FILLED HIS POUCH ONE AND HALF TIMES, THE SECOND EPISODE OF BLEEDING FILLED HIS POUCH, AND THE THIRD EPISODE OF BLEEDING FILLED HIS POUCH HALFWAY. HE STATED HE HAD GONE TO THE EMERGENCY ROOM THREE TIMES THIS YEAR, TWO OF THEM IN APRIL. HE HAD INTERMITTENT BLEEDING THAT WAS USUALLY RESOLVED BY APPLYING PRESSURE FOR SEVERAL MINUTES EXCEPT ON THE OCCASIONS MENTIONED ABOVE. NO LEAKAGE WAS NOTED DURING THESE EPISODES. HE STATED THAT HE CHANGED HIS WAFER WHEN THE BLEEDING OCCURRED. IT WAS FURTHER REPORTED THAT THE CONSTANT SORE WAS NOT CAUSED BY COMPANY¿S DEVICE. HE DID NOT USE ADHESIVE REMOVER TO REMOVE SKIN BARRIER. HE COULD NOT CONFIRM HIS STOMA SIZE. CONSUMER STATED THERE WAS NO HERNIA PRESENT AND HIS ABDOMEN WAS BETWEEN SOFT AND FIRM.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 14872455 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904672 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904667 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904645 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904638 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904635 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904630 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904607 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904602 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904590 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904586 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904582 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904550 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904542 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904539 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904538 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904534 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904484 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904444 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904434 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904412 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904409 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904404 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904402 ↗MalfunctionNov 25, 2020Malposition of Device; Malposition of Device
THE END USER HAD 3 MARKET UNITS WITH 10 SKIN BARRIERS IN EACH BOX THAT HAD MISSHAPED OPENINGS IN THE SKIN BARRIER, NOT ROUND BUT MORE OVAL. HER USUAL WEAR TIME WAS 3 DAYS. THE END USER DECLINED TO USE THESE SKIN BARRIERS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10904396 ↗
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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