NATURA 421458Recalls & reported problems
Convatec, Purchasing Department · Natura® Durahesive® Cut-To-Fit, Accordion Flange 57Mm, 2 1/4" · Class 1
All models of NATURA (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455138340), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED OVER THE PAST MONTH, SHE HAD TO CHANGE THE WAFER MULTIPLE TIMES IN SUCCESSION, WHICH LED TO SKIN TRAUMA. FREQUENT REMOVAL OF THE WAFER CAUSED HER SKIN TO BREAK OPEN, AND SHE BELIEVED THAT STOOL ENTERED THE OPEN AREA, RESULTING IN A BACTERIAL INFECTION. SHE STATED THAT SHE WAS DIAGNOSED WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) AND WAS PRESCRIBED TWO ORAL ANTIBIOTICS DOXYCYCLINE AND ANOTHER SULFUR-BASED MEDICATION SHE COULD NOT RECALL. AT THE TIME OF REPORTING, SHE WAS USING AN UNKNOWN ONE-PIECE PRODUCT AND NOTED THAT HER SKIN WAS IMPROVING. NO PHOTOS WERE AVAILABLE. THE INCIDENT DID NOT RESULT IN BLEEDING OR HOSPITALIZATION BUT DID REQUIRE MEDICAL ATTENTION AND PRESCRIPTION MEDICATION.
Patient problems: Bacterial Infection; Tissue Breakdown
MAUDE report 22967577 ↗
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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