SUR-FIT NATURA 421035Recalls & reported problems
Convatec, Purchasing Department · Natura Moldable Stomahesive Skin Barrier - Accordion Flange With Hydrocolloid Flexible Collar 33-45Mm · Class 1
All models of SUR-FIT NATURA (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Convatec Natura Moldable Stomahesive skin barrier, a moldable wafer used to fit around an ostomy opening. The 30 reports all describe the same issue: the starter hole was off-center, and in each case the product was not used because of it. No patients were involved, so no deaths or injuries are reported. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00768455133093), received between Jan 3, 2020 and Jan 3, 2020 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (30 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 Device30
Patient problems
- No Patient Involvement30
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543865 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543859 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543844 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543836 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543835 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543833 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543832 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543830 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543829 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543828 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543818 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543811 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543802 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543799 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543798 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543797 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543796 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543794 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543788 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543783 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543778 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543773 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543752 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543732 ↗MalfunctionJan 3, 2020Malposition of Device; Malposition of Device
THE NURSE REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 9543727 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page