SUR-FIT NATURA 125263Recalls & reported problems
Convatec, Purchasing Department · SUR-FIT Natura® Stomahesive® Flexible 4" X 4" Wafer Tan 1 1/2 · Class 1
- 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 00768455101764), received between Jul 21, 2023 and Oct 19, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Disintegration” (2 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
- Material Disintegration2
- Material Erosion2
- Positioning Problem2
- Device Emits Odor1
Patient problems
- Diarrhea1
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- Pain1
- Skin Discoloration1
- Skin Tears1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2023Material Disintegration; Material Erosion; Device Emits Odor; Positioning Problem; Material Disintegration; Material Erosion; Device Emits Odor; Positioning Problem
THE END USER REPORTED THAT WEAR TIME WAS LESS THAN ONE DAY WITH THREE WAFERS IN BOX. THE USUAL WEAR TIME OF WAFER WAS TEN DAYS. SHE HAD USED THE SAME WAFER FOR THIRTY YEARS WITH NO ISSUE. ON (B)(6) 2023, SHE NOTED A STRONG CHEMICAL ODOR AFTER HOURS AFTER APPLICATION OF NEW WAFER. THE END USER ALSO STATED THAT THE MASS WAS DISINTEGRATED AND MELTED OFF HER BODY. SHE REPORTED NO CHANGE IN STOMA OR ROUTINE AND STOMA WAS SMALLER THAN 1 INCH. SHE ALSO REPORTED TWO WHITE PATCHES ON HER STOMA. THERE WAS NO BLEEDING OR LACERATION OBSERVED. THE END USER REPORTED THAT SHE SAW AN OSTOMY NURSE TWO WEEKS AGO THEN WHO SAID TO WATCH THEM FOR NOW AND ONE OF THE SPOTS HAD BECOME LARGER SINCE THAT VISIT. SHE ALSO STATED THAT SHE SAVED THE LAST WAFER IN HER FREEZER TO SHOW THE DISINTEGRATION. SHE ALSO HAD TWO UNUSED WAFERS FROM THE BOX. SHE ALSO STATED THAT SHE HAD PLANS TO SEND THEM TO A LAB TO HAVE TESTED. IT WAS HER OPINION SHE WAS EXPOSED TO A CHEMICAL THAT WAS CAUSING THE WHITE SPOTS AND NOW SHE WAS HAVING SEVERE STOMACH PAIN AND DIARRHEA. SHE HAD NOT SLEPT IN THREE DAYS THEN. SHE WAS TRYING TO SEE HER DOCTOR THAT DAY. SHE HAD THROWN THE BOX AWAY AND DOES NOT HAVE LOT NUMBER. CLINICAL INPUT WAS P
Patient problems: Diarrhea; Pain; Skin Discoloration
MAUDE report 17962931 ↗MalfunctionJul 21, 2023Material Disintegration; Material Erosion; Positioning Problem; Material Disintegration; Material Erosion; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Skin Tears
MAUDE report 17369372 ↗
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.