NATURA 411806Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00768455106004), received between Dec 3, 2019 and Feb 27, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Malposition of Device

  THE NURSE REPORTED THAT THE CENTRAL APERTURE OF THE SKIN BARRIER WAFER WAS MISALIGNED. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466016 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462734 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462733 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  IT WAS REPORTED BY THE NURSE THAT THE MOLDABLE MATERIAL OF THE WAFERS WAS CRACKED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462732 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462731 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462730 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462729 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462728 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462727 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  IT WAS REPORTED BY THE NURSE THAT THE MOLDABLE MATERIAL OF THE WAFERS WAS CRACKED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462726 ↗
• MalfunctionJan 8, 2024Material Disintegration; Material Erosion; Material Disintegration; Material Erosion

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462725 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264131 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264129 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264126 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264124 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264122 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264121 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264094 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264093 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem; Material Too Rigid or Stiff; Material Separation; Activation, Positioning or Separation Problem; Separation Problem

  THE END USER REPORTED THAT NINE WAFERS OUT OF ONE BOX OF TEN WAFERS WITH THIS LOT NUMBER WERE STIFFER AND RESULTED IN SEPARATION OF THE WAXY LAYERS WHEN ROLLING OUT THE MOLDABLE BARRIER OPENING, AND AFTER, ABOUT TWO DAYS THE WAFER SPLITS IN TWO, NECESSITATED TO CHANGE APPLIANCE. SHE CHANGED HER WAFER PRIOR TO LEAKAGE AS SHE TOLD THAT IT FELT DIFFERENT. SHE DENIED SKIN IRRITATION AS A RESULT. HER USUAL WEAR TIME WAS FIVE-TO SEVEN DAYS, SHE HAS USED THIS WAFER FOR YEARS WITHOUT CONCERNS AND QUESTIONED STORAGE. SHE USED WITH COMPANY¿S POUCH, SEALS REFERENCE UNKNOWN, OTHER COMPANY¿S BARRIER WIPE AND ADHESIVE REMOVER. SHE DENIED CHANGES IN HER ROUTINE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264092 ↗
• MalfunctionDec 12, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 9456740 ↗
• MalfunctionDec 12, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 9456738 ↗
• MalfunctionDec 12, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 9456737 ↗
• MalfunctionDec 12, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 9456707 ↗
• MalfunctionDec 12, 2019Malposition of Device; Malposition of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 9456704 ↗