SUR-FIT NATURA 421040Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00768455133208), received between Nov 13, 2018 and May 13, 2024 — classified as 2 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (136 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 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297023 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297022 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297021 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297020 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297019 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297018 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297017 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297016 ↗
• MalfunctionMay 13, 2024Melted; Malposition of Device; Positioning Problem; Melted; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297014 ↗
• MalfunctionApr 12, 2024Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE STARTER HOLE OF THE MOLDABLE WAFERS WERE OFF-CENTERED. ALSO, SHE MENTIONED THAT OUT OF ONE MARKET UNIT, HALF OF THE MOLDABLE WAFERS WERE IDENTIFIED AS OFF-CENTERED BEFORE USE. THE PRODUCT WAS USED BY THE END USER AND NO HARM WAS REPORTED. MOREOVER, SHE EXPERIENCED A DECREASE IN WEAR TIME AND BELIEVED THAT IT COULD BE RELATED TO THE ALLEGED ISSUE. ALTHOUGH, SHE MENTIONED THAT SHE HAD SOME ASSESSMENT CHANGES, STOMA WAS NOT PROTRUDING AS MUCH AND ABDOMEN HAD BECOME MORE ROUNDED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094733 ↗
• MalfunctionApr 12, 2024Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE STARTER HOLE OF THE MOLDABLE WAFERS WERE OFF-CENTERED. ALSO, SHE MENTIONED THAT OUT OF ONE MARKET UNIT, HALF OF THE MOLDABLE WAFERS WERE IDENTIFIED AS OFF-CENTERED BEFORE USE. THE PRODUCT WAS USED BY THE END USER AND NO HARM WAS REPORTED. MOREOVER, SHE EXPERIENCED A DECREASE IN WEAR TIME AND BELIEVED THAT IT COULD BE RELATED TO THE ALLEGED ISSUE. ALTHOUGH, SHE MENTIONED THAT SHE HAD SOME ASSESSMENT CHANGES, STOMA WAS NOT PROTRUDING AS MUCH AND ABDOMEN HAD BECOME MORE ROUNDED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094731 ↗
• MalfunctionApr 12, 2024Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER REPORTED THAT THE STARTER HOLE OF THE MOLDABLE WAFERS WERE OFF-CENTERED. ALSO, SHE MENTIONED THAT OUT OF ONE MARKET UNIT, HALF OF THE MOLDABLE WAFERS WERE IDENTIFIED AS OFF-CENTERED BEFORE USE. THE PRODUCT WAS USED BY THE END USER AND NO HARM WAS REPORTED. MOREOVER, SHE EXPERIENCED A DECREASE IN WEAR TIME AND BELIEVED THAT IT COULD BE RELATED TO THE ALLEGED ISSUE. ALTHOUGH, SHE MENTIONED THAT SHE HAD SOME ASSESSMENT CHANGES, STOMA WAS NOT PROTRUDING AS MUCH AND ABDOMEN HAD BECOME MORE ROUNDED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094730 ↗
• MalfunctionApr 12, 2024Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094716 ↗
• MalfunctionApr 12, 2024Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094713 ↗
• InjuryAug 29, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE END USER REPORTED THAT SHE HAD PERISTOMAL SKIN COMPLICATIONS (PSC), DESCRIBING THAT THE PERISTOMAL SKIN UNDER THE MASS AND TAPE COLLAR WAS ITCHY AND HAD A RED RASH. THE WEAR TIME WAS ONE DAY. SHE WAS SEEN AT THE LOCAL WOUND CLINIC AND DIAGNOSED WITH A FUNGAL INFECTION. SHE HAD BEEN GIVEN ORAL NYSTATIN TO TAKE. END USER STATED THAT THE AREA UNDER THE MASS HAD IMPROVED, BUT THE AREA UNDER THE TAPE COLLAR HAD NOT. SHE FELT THAT SHE HAD A COMBINATION OF A YEAST INFECTION TO THE MASS AND AN ALLERGIC REACTION TO THE TAPE. SHE DID NOT REQUIRE ANY MEDICAL ATTENTION AND WAS NOT PRESCRIBED ANY MEDICATION FOR AN ALLERGIC REACTION. THE PATIENT CONTINUED TO USE THE PRODUCT. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Erythema; Fungal Infection; Itching Sensation; Local Reaction; Rash

  MAUDE report 17640245 ↗
• MalfunctionNov 1, 2022Malposition of Device; Malposition of Device

  THE EMDR IS BEING SUBMITTED FOR ONE APPLIANCE WITH KNOWN LOT. THE END USER REPORTED THAT STARTER HOLE OF THE WAFER WAS OFF CENTERED. THE PRODUCT WAS USED ON PATIENT WITH WEAR TIME OF ONE TO TWO DAYS. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE 2019. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705676 ↗
• MalfunctionAug 1, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE END USER STATED THAT THE LAST BOX OF SKIN BARRIERS WAS CAUSING RESTRICTION OF HIS STOMA. IT WAS STATED THAT HE WAS ROLLING THE MATERIAL TO THE MAXIMUM BUT IT WAS ROLLING BACK AND PUTTING PRESSURE ON THE STOMA. THE END USER EXPLAINED THAT THE MOLDABLE MATERIAL WAS NOT HUGGING THE STOMA WHICH THE MATERIAL SUPPOSED TO DO. HE STILL HAD AN OUTPUT BUT FELT LESS THAN BEFORE. HE HAD USED FOUR OUT OF THE BOX SO FAR AND APPLIED A NEW ONE ON THE PREVIOUS DAY OF REPORTING. HIS STOMA WAS BIGGER THAN NORMAL, HOWEVER, HE WAS NOT SURE WHEN IT GOT BIGGER. IT WAS MARKED IN THE FILE THAT HIS STOMA WAS MEASURED TWENTY-TWO (22) MM IN THE PAST. HE DID NOT COMPLAIN OF ANY PAIN OR BLEEDING OF THE STOMA AND DENIED HERNIA AS WELL. HE ALSO SCHEDULED AN APPOINTMENT WITH THE NURSE ON WEDNESDAY. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 15137559 ↗
• MalfunctionAug 1, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE END USER STATED THAT THE LAST BOX OF SKIN BARRIERS WAS CAUSING RESTRICTION OF HIS STOMA. IT WAS STATED THAT HE WAS ROLLING THE MATERIAL TO THE MAXIMUM BUT IT WAS ROLLING BACK AND PUTTING PRESSURE ON THE STOMA. THE END USER EXPLAINED THAT THE MOLDABLE MATERIAL WAS NOT HUGGING THE STOMA WHICH THE MATERIAL SUPPOSED TO DO. HE STILL HAD AN OUTPUT BUT FELT LESS THAN BEFORE. HE HAD USED FOUR OUT OF THE BOX SO FAR AND APPLIED A NEW ONE ON THE PREVIOUS DAY OF REPORTING. HIS STOMA WAS BIGGER THAN NORMAL, HOWEVER, HE WAS NOT SURE WHEN IT GOT BIGGER. IT WAS MARKED IN THE FILE THAT HIS STOMA WAS MEASURED TWENTY-TWO (22) MM IN THE PAST. HE DID NOT COMPLAIN OF ANY PAIN OR BLEEDING OF THE STOMA AND DENIED HERNIA AS WELL. HE ALSO SCHEDULED AN APPOINTMENT WITH THE NURSE ON (B)(6). NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 15137558 ↗
• MalfunctionAug 1, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE END USER STATED THAT THE LAST BOX OF SKIN BARRIERS WAS CAUSING RESTRICTION OF HIS STOMA. IT WAS STATED THAT HE WAS ROLLING THE MATERIAL TO THE MAXIMUM BUT IT WAS ROLLING BACK AND PUTTING PRESSURE ON THE STOMA. THE END USER EXPLAINED THAT THE MOLDABLE MATERIAL WAS NOT HUGGING THE STOMA WHICH THE MATERIAL SUPPOSED TO DO. HE STILL HAD AN OUTPUT BUT FELT LESS THAN BEFORE. HE HAD USED FOUR OUT OF THE BOX SO FAR AND APPLIED A NEW ONE ON THE PREVIOUS DAY OF REPORTING. HIS STOMA WAS BIGGER THAN NORMAL, HOWEVER, HE WAS NOT SURE WHEN IT GOT BIGGER. IT WAS MARKED IN THE FILE THAT HIS STOMA WAS MEASURED TWENTY-TWO (22) MM IN THE PAST. HE DID NOT COMPLAIN OF ANY PAIN OR BLEEDING OF THE STOMA AND DENIED HERNIA AS WELL. HE ALSO SCHEDULED AN APPOINTMENT WITH THE NURSE ON WEDNESDAY. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 15137556 ↗
• MalfunctionAug 1, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE END USER STATED THAT THE LAST BOX OF SKIN BARRIERS WAS CAUSING RESTRICTION OF HIS STOMA. IT WAS STATED THAT HE WAS ROLLING THE MATERIAL TO THE MAXIMUM BUT IT WAS ROLLING BACK AND PUTTING PRESSURE ON THE STOMA. THE END USER EXPLAINED THAT THE MOLDABLE MATERIAL WAS NOT HUGGING THE STOMA WHICH THE MATERIAL SUPPOSED TO DO. HE STILL HAD AN OUTPUT BUT FELT LESS THAN BEFORE. HE HAD USED FOUR OUT OF THE BOX SO FAR AND APPLIED A NEW ONE ON THE PREVIOUS DAY OF REPORTING. HIS STOMA WAS BIGGER THAN NORMAL, HOWEVER, HE WAS NOT SURE WHEN IT GOT BIGGER. IT WAS MARKED IN THE FILE THAT HIS STOMA WAS MEASURED TWENTY-TWO (22) MM IN THE PAST. HE DID NOT COMPLAIN OF ANY PAIN OR BLEEDING OF THE STOMA AND DENIED HERNIA AS WELL. HE ALSO SCHEDULED AN APPOINTMENT WITH THE NURSE ON WEDNESDAY. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 15137523 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED TO THE SPECIALIST THAT ONE OUT OF TEN WAFERS CAUSED BRIGHT RED INFLAMED SKIN UNDER ENTIRE TAPE COLLAR. SAW HER PRIMARY CARE PHYSICIAN WHO DIAGNOSED HER WITH A YEAST INFECTION AND PRESCRIBED AN ORAL ANTI-FUNGAL MEDICATION FOR THIRTY DAYS AND AN ANTI-FUNGAL CREAM WHICH WAS RECENTLY DISCONTINUED BY THE DERMATOLOGIST. SHE SAW THE DERMATOLOGIST GAVE A PRESCRIPTION FOR NASONEX SPRAY TO THE AREA AS WELL AS PRESCRIPTION BETAMETHASONE OINTMENT COVERED BY TEGADERM WHICH CAUSED BLISTERING TO THE PERISTOMAL SKIN TO EDGE OF THE TAPE COLLAR. BLISTERS WERE IMPROVED AND NOW SCABBED OVER WITH THE USE OF THE NASONEX. IT WAS UNKNOWN IF THE PATIENT WAS STILL USING THE PRODUCT OR NOT. THE END USER WAS INSTRUCTED TO TEMPORARILY STOP USING TAPE COLLAR. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Blister; Burning Sensation; Erythema; Fungal Infection; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 13625700 ↗
• MalfunctionJun 9, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132245 ↗
• MalfunctionJun 9, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132244 ↗
• MalfunctionJun 9, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132222 ↗
• MalfunctionJun 9, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE END USER STATED THAT 10 OUT OF 10 WAFERS FROM THIS BOX HAD AN OFF CENTERED STARTER HOLE AND SHE FELT LIKE THIS HAD CONTRIBUTED TO HER POOR WEAR TIME. SHE HAD ONLY USED ONE FROM THIS BOX. REPORTEDLY, HER USUAL WEAR TIME WAS 3-5 DAYS AND NOW, WEAR TIME WAS 1-2. SHE HAD NOT CHANGED ANYTHING IN HER ROUTINE OR WEIGHT. THERE WAS NO HARM REPORTED AND A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132221 ↗