NATURA 411801Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Moldable Stomahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1 3/4" ) - Small] · Class 1
Quick summary
This Convatec SUR-FIT Natura moldable ostomy skin barrier is a small wafer applied around a stoma. Most of the 75 reports describe the barrier sitting in the wrong position after placement (70), and a few describe the moldable material crumbling or breaking apart while being shaped (5). None of the reports involve deaths or 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
- 75
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00768455105953), received between Dec 5, 2018 and Aug 29, 2022 — classified as 75 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (70 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.
Most reported problems
Device problems
- Malposition of Device70
- Material Disintegration5
Patient problems
- No Consequences Or Impact To Patient70
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2022Material Disintegration; Material Disintegration
THE END USER REPORTED THAT MOLDABLE STOMAHESIVE (SH) WAFER MASS CRUMBLED IN THREE REPLACEMENT WAFERS FROM ONE SAMPLE PACK OF THREE WAFERS. SHE RECEIVED THE WAFER SAMPLES ON (B)(6) 2022. AN ELECTRONIC MAIL(EMAIL) WITH ATTACHED PICTURES WAS RECEIVED WHICH ALSO READ AND DISPLAYED THE CRUMBLING OF THE WAFER THAT OCCURRED WHILE THE END USER WAS MOLDING THE COLLAR FOR TURTLE NECKING AROUND HER STOMA. THE END USER STATED AND HOPED THAT THESE PROVIDED PICTURES WOULD BETTER EXPLAIN HER EXPERIENCE AND HELP WITH PRODUCT QUALITY INVESTIGATION. THE SAME ISSUE OCCURRED DURING HER VIRTUAL VISIT WITH NURSE, BUT NO PICTURES WERE TAKEN THEN. THIS ISSUE WAS ALREADY REPORTED. THE END USER ALSO REPORTED THAT SHE PROVIDED THE LOT NUMBER FOR THE FIRST INCIDENT WHICH WAS FOUND SAME FOR REPLACEMENT PRODUCTS AS WELL AND THE PICTURES AND PACKING LIST WERE PROVIDED FOR THE SECOND SET OF MOLDABLE WAFERS. ON (B)(6) 2022, SHE CHANGED HER APPLIANCE AND ONE OF THE THREE MOLDABLE STOMAHESIVE WAFERS. AS PER THE CONTROLLED SINGLE VARIABLE-AT-A-TIME ELIMINATION PLAN, THAT HER NURSE ESTABLISHED DURING HER VIRTUAL MEDICAL EXAM IN WHICH IT WAS DISCUSSED NOT USING POWDER OR CRUSTING STEP FIRSTLY, SHE SAID THAT SHE HAD NOT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15309555 ↗MalfunctionAug 29, 2022Material Disintegration; Material Disintegration
THE END USER REPORTED THAT MOLDABLE STOMAHESIVE (SH) WAFER MASS CRUMBLED IN THREE REPLACEMENT WAFERS FROM ONE SAMPLE PACK OF THREE WAFERS. SHE RECEIVED THE WAFER SAMPLES ON TUESDAY, (B)(6) 2022. AN ELECTRONIC MAIL(EMAIL) WITH ATTACHED PICTURES WAS RECEIVED WHICH ALSO READ AND DISPLAYED THE CRUMBLING OF THE WAFER THAT OCCURRED WHILE THE END USER WAS MOLDING THE COLLAR FOR TURTLE NECKING AROUND HER STOMA. THE END USER STATED AND HOPED THAT THESE PROVIDED PICTURES WOULD BETTER EXPLAIN HER EXPERIENCE AND HELP WITH PRODUCT QUALITY INVESTIGATION. THE SAME ISSUE OCCURRED DURING HER VIRTUAL VISIT WITH NURSE, BUT NO PICTURES WERE TAKEN THEN. THIS ISSUE WAS ALREADY REPORTED. THE END USER ALSO REPORTED THAT SHE PROVIDED THE LOT NUMBER FOR THE FIRST INCIDENT WHICH WAS FOUND SAME FOR REPLACEMENT PRODUCTS AS WELL AND THE PICTURES AND PACKING LIST WERE PROVIDED FOR THE SECOND SET OF MOLDABLE WAFERS. ON WEDNESDAY, (B)(6) 2022, SHE CHANGED HER APPLIANCE AND ONE OF THE THREE MOLDABLE STOMAHESIVE WAFERS. AS PER THE CONTROLLED SINGLE VARIABLE-AT-A-TIME ELIMINATION PLAN, THAT HER NURSE ESTABLISHED DURING HER VIRTUAL MEDICAL EXAM IN WHICH IT WAS DISCUSSED NOT USING POWDER OR CRUSTING STEP FIRSTLY, SHE S
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15309551 ↗MalfunctionAug 29, 2022Material Disintegration; Material Disintegration
THE END USER REPORTED THAT MOLDABLE STOMAHESIVE (SH) WAFER MASS CRUMBLED IN THREE REPLACEMENT WAFERS FROM ONE SAMPLE PACK OF THREE WAFERS. SHE RECEIVED THE WAFER SAMPLES ON TUESDAY, (B)(6) 2022. AN ELECTRONIC MAIL(EMAIL) WITH ATTACHED PICTURES WAS RECEIVED WHICH ALSO READ AND DISPLAYED THE CRUMBLING OF THE WAFER THAT OCCURRED WHILE THE END USER WAS MOLDING THE COLLAR FOR TURTLE NECKING AROUND HER STOMA. THE END USER STATED AND HOPED THAT THESE PROVIDED PICTURES WOULD BETTER EXPLAIN HER EXPERIENCE AND HELP WITH PRODUCT QUALITY INVESTIGATION. THE SAME ISSUE OCCURRED DURING HER VIRTUAL VISIT WITH NURSE, BUT NO PICTURES WERE TAKEN THEN. THIS ISSUE WAS ALREADY REPORTED. THE END USER ALSO REPORTED THAT SHE PROVIDED THE LOT NUMBER FOR THE FIRST INCIDENT WHICH WAS FOUND SAME FOR REPLACEMENT PRODUCTS AS WELL AND THE PICTURES AND PACKING LIST WERE PROVIDED FOR THE SECOND SET OF MOLDABLE WAFERS. ON WEDNESDAY, (B)(6) 2022, SHE CHANGED HER APPLIANCE AND ONE OF THE THREE MOLDABLE STOMAHESIVE WAFERS. AS PER THE CONTROLLED SINGLE VARIABLE-AT-A-TIME ELIMINATION PLAN, THAT HER NURSE ESTABLISHED DURING HER VIRTUAL MEDICAL EXAM IN WHICH IT WAS DISCUSSED NOT USING POWDER OR CRUSTING STEP FIRSTLY, SHE S
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15309550 ↗MalfunctionAug 9, 2022Material Disintegration; Material Disintegration
THE END USER REPORTED THAT WHEN SHE TRIED TO MOLD ONE WAFER FROM THE SAMPLE PACK OF THREE, THE MOLDABLE PORTION OF WAFER MASS CRUMBLED. SHE DID NOT USED THE PRODUCT. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189586 ↗MalfunctionAug 9, 2022Material Disintegration; Material Disintegration
THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF WAFERS FOR UNKNOWN MARKET UNITS FOR UNKNOWN NUMBER OF EVENTS HAPPENED PREVIOUSLY. THE END USER REPORTED THAT WHEN SHE TRIED TO MOLD THE WAFER, THE MOLDABLE PORTION OF THE WAFER MASS CRUMBLED. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189579 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506998 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506995 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506994 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506993 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506992 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506965 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506963 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506959 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506958 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506953 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506951 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506949 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506948 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506947 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506946 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT 5 BOXES (50 APPLIANCES) HAD AN OFF CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506945 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506944 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506943 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506759 ↗MalfunctionSep 9, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT 5 BOXES (50 APPLIANCES) HAD AN OFF CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10506758 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.