NATURA 411802Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1 3/4" ) - Medium] · Class 1
Quick summary
This Convatec Natura ostomy skin barrier is a flange that sits around a stoma. Most of its 966 reports describe the barrier being in the wrong position, and a few describe leaks and blocked openings. The reports mention no deaths and 1 injury. 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
- 966
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 966 adverse event reports that list this exact device (DI 00768455105960), received between Sep 21, 2018 and Aug 11, 2026 — classified as 1 injury, 965 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (944 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device944
- Positioning Problem66
- Fluid/Blood Leak29
- Material Disintegration8
- Material Too Rigid or Stiff8
- Complete Blockage7
- Material Protrusion/Extrusion7
- Obstruction of Flow7
Patient problems
- No Patient Involvement446
- No Consequences Or Impact To Patient317
- No Clinical Signs, Symptoms or Conditions174
- Discomfort23
- Blood Loss14
- Tissue Damage14
- Pain8
- Hemorrhage/Blood Loss/Bleeding7
Recent adverse event reports
The 25 most recent of 966 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206400 ↗MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206395 ↗MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206394 ↗MalfunctionAug 11, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206373 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25239126 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25239033 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238889 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238888 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238887 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238885 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238884 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238883 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238881 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238880 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238878 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238877 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238809 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238808 ↗MalfunctionMay 21, 2026Malposition of Device
THE END USER REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238803 ↗MalfunctionMay 8, 2026Malposition of Device
THE CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122111 ↗MalfunctionMay 8, 2026Malposition of Device
THE CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122110 ↗MalfunctionMay 8, 2026Malposition of Device
THE CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122109 ↗MalfunctionMay 8, 2026Malposition of Device
THE CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122107 ↗MalfunctionMay 8, 2026Malposition of Device
THE CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122106 ↗MalfunctionMay 8, 2026Malposition of Device
THE CUSTOMER REPORTED THAT TEN WAFERS (MOLDABLE) FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF-CENTERED STARTER HOLE PRIOR TO USE, MAKING THE PRODUCT UNUSABLE. THE CUSTOMER WAS A LONG-TIME USER OF THE PRODUCT, USUALLY HAD A WEAR TIME OF THREE DAYS. THERE WAS A HISTORY OF MULTIPLE COMPLAINTS RELATED TO THE SAME ISSUE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122105 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.