NATURA 411800Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00768455105946), received between Oct 3, 2022 and Aug 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Complete Blockage; Melted; Material Protrusion/Extrusion; Complete Blockage; Melted; Material Protrusion/Extrusion

  THE END USER REPORTED THAT THE BOX OF THREE SKIN BARRIERS HAD A SERIOUS MASS MELTING PROBLEM, WHICH HAD ALSO BLOCKED THE EXCRETION OUTLET. IT HAD BEEN CONFIRMED THAT OBSTRUCTION HAD FULLY BLOCKED THE STOMA. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714385 ↗
• MalfunctionAug 5, 2025Complete Blockage; Melted; Material Protrusion/Extrusion; Complete Blockage; Melted; Material Protrusion/Extrusion

  THE END USER REPORTED THAT THE BOX OF THREE SKIN BARRIERS HAD A SERIOUS MASS MELTING PROBLEM, WHICH HAD ALSO BLOCKED THE EXCRETION OUTLET. IT HAD BEEN CONFIRMED THAT OBSTRUCTION HAD FULLY BLOCKED THE STOMA. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714384 ↗
• MalfunctionAug 5, 2025Complete Blockage; Melted; Material Protrusion/Extrusion; Complete Blockage; Melted; Material Protrusion/Extrusion

  THE END USER REPORTED THAT THE BOX OF THREE SKIN BARRIERS HAD A SERIOUS MASS MELTING PROBLEM, WHICH HAD ALSO BLOCKED THE EXCRETION OUTLET. IT HAD BEEN CONFIRMED THAT OBSTRUCTION HAD FULLY BLOCKED THE STOMA. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714246 ↗
• MalfunctionApr 12, 2024Material Disintegration; Positioning Problem; Material Disintegration; Positioning Problem

  THE END USER REPORTED THAT HE HAD CUT HIS STOMA WITH THE APPLIANCE. HE USED THE COMPANY'S PRODUCT AND MENTIONED THAT THERE WAS A PIECE OF PLASTIC EMBEDDED IN THE MOLDABLE MATERIAL OF WAFER. HE HAD ROLLED THE MATERIAL OPEN, AND IT HAD CUT HIS STOMA. HE HAD TO REMOVE THE APPLIANCE AFTER ONE DAY OF WEAR AS IT HAD BEEN BLEEDING AND CAUSING THE APPLIANCE TO LIFT. HE THEN HAD TO CHANGE HIS APPLIANCE DAILY DUE TO THE BLEEDING. THE AMOUNT OF BLEEDING DECREASED OVER THE TEN DAYS FOLLOWING THE INJURY, AND IT NOW ONLY BLED WHEN THE STOMA WAS CLEANED. THE CONSUMER USED COMPANY'S STOMA POWDER AND DID NOT REQUIRE ANY OTHER MEDICAL INTERVENTION OR TREATMENT. THE END USER ADDITIONALLY STATED THAT HE DID NOT HAVE ANY PHOTOS AS THE INCIDENT OCCURRED WHILE HE WAS ON VACATION, AND HE HAD DISPOSED OF THE WAFER AFTER REPLACING IT WITH ANOTHER ONE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Tissue Breakdown

  MAUDE report 19094847 ↗
• MalfunctionOct 3, 2022Material Disintegration; Material Disintegration

  THE END USER REPORTED THAT A PORTION OF MASS DISSOLVED REVEALING THE PLASTIC LINER IN ONE WAFER OUT OF SAMPLE PACK OF THREE. HE STATED THAT THE PLASTIC LINER HAD BEEN IN CONTACT WITH HIS STOMA AND CAUSED IRRITATION AND A TRACE AMOUNT OF BLOOD FROM HIS STOMA. THE BLEEDING DID NOT CONTINUE, AND HE DID NOT HAVE TO APPLY PRESSURE TO THE AREA OR SEEK MEDICAL TREATMENT. THIS WAS THE FIRST TIME THE CONSUMER HAD USED THIS WAFER. HE HAD THE WAFER ON APPLICATION FOR FOUR DAYS AND HAD BEEN USING THE CURRENT PRODUCT FOR LESS THAN FOUR MONTHS. HE FURTHER STATED THAT HE HAD WORN A SIMILAR COMPANY¿S WAFER WITHOUT ANY ISSUE, AND HE WILL CONTINUE TO USE THE SAME. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation

  MAUDE report 15527221 ↗