SUR-FIT NATURA 413183Recalls & 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 1/4" (32Mm.) · 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 has 773 FDA reports, all of them malfunctions, with no deaths and no injuries. Reports describe the wafer's opening being off-center, and some mention positioning problems and fluid leaks. Most reports note no effect on patients. There are no recalls naming 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
- 773
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 773 adverse event reports that list this exact device (DI 00768455106431), received between Nov 12, 2019 and Jan 29, 2024 — classified as 773 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (773 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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device773
- Positioning Problem138
- Fluid/Blood Leak15
Patient problems
- No Consequences Or Impact To Patient560
- No Patient Involvement187
- No Clinical Signs, Symptoms or Conditions25
- Unspecified Infection1
- Urinary Tract Infection1
Recent adverse event reports
The 25 most recent of 773 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTER HOLE. THE CUSTOMER WAS CONTACTED DIRECTLY AFTERWARDS. THE END USER STATED THAT HE WAS A LONG-TIME USER AND RECENTLY RECEIVED PRODUCTS WITH OFF-CENTER OPENINGS. ALSO, CLARIFIED IT WAS THE OPENING AND NOT THE MASS ASSEMBLY. THE PRODUCT FROM THIS MARKET UNIT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597248 ↗MalfunctionJan 29, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTER HOLE. THE CUSTOMER WAS CONTACTED DIRECTLY AFTERWARDS. THE END USER STATED THAT HE WAS A LONG-TIME USER AND RECENTLY RECEIVED PRODUCTS WITH OFF-CENTER OPENINGS. ALSO, CLARIFIED IT WAS THE OPENING AND NOT THE MASS ASSEMBLY. THE PRODUCT FROM THIS MARKET UNIT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597246 ↗MalfunctionJan 29, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTER HOLE. THE CUSTOMER WAS CONTACTED DIRECTLY AFTERWARDS. THE END USER STATED THAT HE WAS A LONG-TIME USER AND RECENTLY RECEIVED PRODUCTS WITH OFF-CENTER OPENINGS. ALSO, CLARIFIED IT WAS THE OPENING AND NOT THE MASS ASSEMBLY. THE PRODUCT FROM THIS MARKET UNIT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597243 ↗MalfunctionJan 29, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTER HOLE. THE CUSTOMER WAS CONTACTED DIRECTLY AFTERWARDS. THE END USER STATED THAT HE WAS A LONG-TIME USER AND RECENTLY RECEIVED PRODUCTS WITH OFF-CENTER OPENINGS. ALSO, CLARIFIED IT WAS THE OPENING AND NOT THE MASS ASSEMBLY. THE PRODUCT FROM THIS MARKET UNIT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597242 ↗MalfunctionJan 29, 2024Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTER HOLE. THE CUSTOMER WAS CONTACTED DIRECTLY AFTERWARDS. THE END USER STATED THAT HE WAS A LONG-TIME USER AND RECENTLY RECEIVED PRODUCTS WITH OFF-CENTER OPENINGS. ALSO, CLARIFIED IT WAS THE OPENING AND NOT THE MASS ASSEMBLY. THE PRODUCT FROM THIS MARKET UNIT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597238 ↗MalfunctionFeb 11, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512182 ↗MalfunctionFeb 11, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512180 ↗MalfunctionFeb 11, 2022Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512179 ↗MalfunctionFeb 11, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512178 ↗MalfunctionFeb 11, 2022Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512132 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867816 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867812 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867810 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867780 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867777 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867762 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867758 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867757 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867755 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867754 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867750 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867696 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867693 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867692 ↗MalfunctionNov 24, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12867691 ↗
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
- 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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