NATURA 404594Recalls & reported problems

Summary

The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 00768455104543), received between Nov 14, 2018 and Jun 2, 2025 — classified as 1 injury, 329 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (323 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 25 most recent of 330 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device

  THE END USER REPORTED THAT THE STARTER HOLE OF COMPANY'S PRODUCT WAS OFF CENTERED WHICH RESULTED IN LEAKAGE. HE HAD TO CHANGE THE SAME DAY, WHEN HE USUALLY GETS FIVE TO SIX DAYS WEAR TIME. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121916 ↗
• MalfunctionDec 29, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER CALLED AND REPORTED THAT HE FOUND THE COMPANY'S KNOWN WAFER'S MASS MATERIAL WAS VERY STIFF, NOT EASY TO WORK WITH WHEN HE WAS TRYING TO MOLD IT AND APPLY TO SKIN. THERE WAS NO VISIBLE DIFFERENCE WHEN HE LOOKS AT THE PRODUCT. HE NORMALLY GETS SIX TO TEN DAYS WEAR TIME WITH THE PRODUCTS. THE PRODUCT WAS USED ON THE PATIENT AND NO HARM WAS REPORTED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417835 ↗
• MalfunctionDec 29, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER CALLED AND REPORTED THAT HE FOUND THE COMPANY'S KNOWN WAFER'S MASS MATERIAL WAS VERY STIFF, NOT EASY TO WORK WITH WHEN HE WAS TRYING TO MOLD IT AND APPLY TO SKIN. THERE WAS NO VISIBLE DIFFERENCE WHEN HE LOOKS AT THE PRODUCT. HE NORMALLY GETS SIX TO TEN DAYS WEAR TIME WITH THE PRODUCTS. THE PRODUCT WAS USED ON THE PATIENT AND NO HARM WAS REPORTED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417834 ↗
• InjurySep 2, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF WAFERS FROM THREE MARKET UNITS OF TEN WAFERS. THE PRODUCTS WERE PREVIOUSLY ORDERED FROM MEDICAL EQUIPMENT COMPANY. THE CONSUMER'S SON REPORTED THAT END USER WAS IN THE EMERGENCY ROOM PER PCP (PRIMARY CARE PHYSICIAN) ADVISEMENT. HE REPORTED PARASTOMAL SKIN INFECTION ON THE AFFECTED AREA BELOW THE STOMA. THIS EVENT WAS STARTED A COUPLE OF MONTHS AGO AND WAS FOLLOWING UP WITH PCP. THE ISSUE STARTED WHEN RETAILER CHANGED THE END USER¿S PRODUCT. CUSTOMER'S SON SUSPECTED THAT CONSUMER DEVELOPED SENSITIVITY TO WAFER. THE PRODUCT HAD NOT BEEN ADHERING WELL DUE TO THE IRRITATION. SHE WAS USING TOPICAL MEDICATIONS MUPIROCIN, AN ANTIBIOTIC OINTMENT, ON PARASTOMAL SKIN ORDERED BY DOCTOR OF MEDICINE(MD) BUT STATED THAT IT ALSO KEPT THE APPLIANCE FROM ADHERING. HE WAS NOT SURE OF THE FREQUENCY OF APPLICATION OF THE MUPIROCIN. HE REPORTED SOME BLEEDING, BUT IT WAS UNABLE TO QUANTIFY THE BLOOD. EMERGENCY ROOM DOCTOR WOULD ADMIT CONSUMER TO HOSPITAL FOR FORTY-EIGHT HOURS FOR INFECTION FOR INTRAVENOUS (IV) ANTIBIOTICS. GENERAL SURGEON SAID CT (COMPUTED TOMOGRAPHY SCAN) CONFIRMED PARASTOMAL INTRAABDOMINAL INFECTION. HE WAS ORDERING ALTERNATE PRODU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Skin Infection; Skin Inflammation/ Irritation; Tissue Breakdown; Ulcer

  MAUDE report 15344541 ↗
• MalfunctionFeb 2, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE MASS WAS VERY RIGID. IT USED TO BE SOFTER. THE END USER STATED THAT IT WAS SO RIGID THAT IT CAUSED A VERY SMALL ROUND PIMPLE SIZE SORE NEXT TO HER STOMA. SHE ALSO STATED THAT THE SORE WAS OPEN, AND BLEEDING OCCURRED. SHE STATED THAT IT WAS PAINFUL ESPECIALLY WHEN SHE MOVED. SHE FURTHER MENTIONED THAT SHE WAS VERY ACTIVE, AND IT WAS HER OPINION THE RIGID MASS RUBBED THE SKIN WHEN SHE MOVED. SHE FIRST NOTICED THE SORE ON SATURDAY ON (B)(6). SHE APPLIED A STYPTIC PENCIL TO THE AREA. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 13421234 ↗
• MalfunctionOct 22, 2021Fluid/Blood Leak; Malposition of Device; Positioning Problem; Fluid/Blood Leak; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT ABOUT HALF INCH OPENING IN ONE WAFER APPEARED OFF CENTERED. SHE ALSO REPORTED DECREASE IN WEAR TIME TO ONE DAY WITH LEAKAGE AND SKIN IRRITATION. SHE REPORTED DIPS IN SKIN NEAR HER STOMA WHICH SHE FILLED WITH PASTE OR RINGS. NO PHOTO IS AVAILABLE AT THIS TIME SINCE SHE HAD DISPOSED OF PACKAGING AND BOXES.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12679622 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479661 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479660 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479659 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479656 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479655 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479628 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479626 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479625 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479624 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479623 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479622 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479621 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479620 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479619 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479598 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479597 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479596 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479595 ↗
• MalfunctionSep 16, 2021Malposition of Device; Malposition of Device

  THE END USER VISUALLY INSPECTED THE WAFERS AND FOUND THAT THE MOLDABLE HOLE WAS OFF CENTERED IN 20 WAFERS FROM 2 MARKET UNITS PRIOR TO USE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479593 ↗