SUR-FIT NATURA 421041Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00768455133215), received between Feb 15, 2019 and Jul 7, 2025 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409720 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409719 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409718 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409715 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409712 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409709 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409669 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409668 ↗
• MalfunctionJul 7, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CONSUMER REPORTED THAT THE NINE MOLDABLE WAFERS FROM ONE MARKET UNIT WAS STIFFER AND LESS PLIABLE THAN USUAL, MAKING IT DIFFICULT TO MOLD AND KEEP IN PLACE. ALTHOUGH WEAR TIME REMAINED UNAFFECTED (TYPICALLY THREE TO FOUR DAYS), SHE NOTICED A DIFFERENCE IN THE ADHESIVE'S FEEL. THE STOMA SIZE AND CONTOURS WERE UNCHANGED, WITH THE STOMA AT THE PRODUCT'S MAXIMUM MOLD-TO-FIT SIZE OF FORTY-FIVE MILLIMETER (MM). THERE WAS NO HARM REPORTED. SHE BEGAN USING A NEW MARKET UNIT AND FOUND ITS FLEXIBILITY AND MOLDABILITY TO BE AS EXPECTED. NO PHOTO OR FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409664 ↗
• InjuryOct 12, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

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

  Patient problems: Arthralgia; Erythema; Hypersensitivity/Allergic reaction; Inflammation; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17923327 ↗
• MalfunctionJun 4, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE WAFER HAD AN OFF CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Patient Involvement

  MAUDE report 10117617 ↗
• MalfunctionJun 4, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE WAFER HAD AN OFF CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Patient Involvement

  MAUDE report 10117609 ↗
• MalfunctionJun 4, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Patient Involvement

  MAUDE report 10117589 ↗
• MalfunctionJun 4, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Patient Involvement

  MAUDE report 10117588 ↗
• MalfunctionApr 15, 2020Malposition of Device; Malposition of Device

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

  Patient problems: No Patient Involvement

  MAUDE report 9961656 ↗
• MalfunctionApr 15, 2020Malposition of Device; Malposition of Device

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

  Patient problems: No Patient Involvement

  MAUDE report 9961655 ↗
• MalfunctionApr 13, 2020Malposition of Device; Malposition of Device

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

  Patient problems: No Patient Involvement

  MAUDE report 9952037 ↗
• MalfunctionNov 12, 2019Malposition of Device; Malposition of Device

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313384 ↗
• MalfunctionSep 30, 2019Malposition of Device; Malposition of Device

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135202 ↗
• MalfunctionSep 30, 2019Malposition of Device; Malposition of Device

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9134603 ↗
• MalfunctionSep 30, 2019Malposition of Device; Malposition of Device

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9134550 ↗
• MalfunctionSep 30, 2019Malposition of Device; Malposition of Device

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9134384 ↗
• MalfunctionSep 23, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE WAFER HAD OFF CENTERED STARTER HOLE. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105813 ↗
• MalfunctionSep 23, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE WAFER HAD OFF CENTERED STARTER HOLE. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105382 ↗
• MalfunctionSep 23, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE WAFER HAD OFF CENTERED STARTER HOLE. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105366 ↗