SUR-FIT NATURA 421039Recalls & reported problems
Convatec, Purchasing Department · Natura Moldable Durahesive Skin Barrier - Accordion Flange With Hydrocolloid Flexible Collar 13-22Mm · Class 1
All models of SUR-FIT NATURA (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455133192), received between Sep 26, 2022 and Sep 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (1 report).
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 Device1
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2024Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT ONE WAFER FROM A SAMPLE PACKAGE HAD STARTER HOLE OFF CENTERED. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20277231 ↗MalfunctionSep 26, 2022Material Disintegration; Material Disintegration
THE END USER CALLED AND REPORTED THAT SHE TRIED TO ROLL THE CENTER OF HER MOLDABLE WAFER AND IT ALL FELL APART TO PIECES WHEN MOLDING. THE PRODUCT WAS NOT USED AND NO HARM WAS REPORTED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484691 ↗
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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