SUR-FIT NATURA 413418Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00768455123926), received between Nov 29, 2018 and Apr 28, 2023 — classified as 97 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (71 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 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830503 ↗
• MalfunctionApr 21, 2023Sharp Edges; Sharp Edges

  THE END USER REPORTED THAT FROM ONE WAFER OUT OF THREE SAMPLE PACK OF THREE, HE HAD OBSERVED A HARD EDGE AT THE STARTER HOLE WHEN IT WAS REMOVED AND NOTED THERE WAS LESS THAN A TEASPOON OF BLOOD AT THE BASE OF STOMA WHERE STOMA MET THE SKIN WHICH WAS RESOLVED ON ITS OWN. HIS WIFE DID NOT SEE ANY OPEN AREAS ON STOMA, BUT STOMA WAS DEFORMED AS IT WAS SQUEEZED TOO HARD. IT WAS CLARIFIED LATER THAT THE STOMA WAS NOT CONSTRICTED AND THE WAFER WAS THE CORRECT SIZE. IT WAS THE END USER'S PERCEPTION THAT IT WAS DEFORMED BUT END USER'S WIFE CONFIRMED IT WAS NOT DEFORMED, AS SHE CHANGES THE POUCH. HE ALSO STATED HE WAS NEW TO OUR COMPANY¿S PRODUCT AND HE DOES NOT WANT TO CHANGE FROM THIS PRODUCT BECAUSE HE DID NOT HAVE ANY LEAKAGE ISSUES. THE PRODUCT WAS USED FOR THREE TO FOUR DAYS. FURTHERMORE, IT WAS CONFIRMED THAT NO EXCESSIVE FORCE WAS REQUIRED TO REMOVE FROM SKIN AND ADDITIONALLY CONFIRMED THAT THE HARD EDGE OF WAFER WAS FACING VERTICALLY TO THE STOMA, NOT THE SKIN. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16782762 ↗
• MalfunctionFeb 23, 2023Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425835 ↗
• MalfunctionDec 5, 2022Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914013 ↗
• MalfunctionDec 5, 2022Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT THE STARTER HOLE OF FIVE OUT OF TEN SKIN BARRIERS WAS OFF CENTERED. 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 15914006 ↗
• MalfunctionDec 5, 2022Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT THE STARTER HOLE OF FIVE OUT OF TEN SKIN BARRIERS WAS OFF CENTERED. 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 15914004 ↗
• MalfunctionDec 5, 2022Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT THE STARTER HOLE OF FIVE OUT OF TEN SKIN BARRIERS WAS OFF CENTERED. 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 15914002 ↗
• MalfunctionDec 5, 2022Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914000 ↗
• MalfunctionMar 1, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT SIX WAFERS WERE DRIED OUT AND HARD TO MOLD PRIOR TO USE. SHE USED THE PRODUCT, AND IT DID NOT PERFORM FOR HER AS A RESULT OF IT BEING DRIED OUT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633061 ↗
• MalfunctionMar 1, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT SIX WAFERS WERE DRIED OUT AND HARD TO MOLD PRIOR TO USE. SHE USED THE PRODUCT, AND IT DID NOT PERFORM FOR HER AS A RESULT OF IT BEING DRIED OUT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633044 ↗
• MalfunctionMar 1, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT SIX WAFERS WERE DRIED OUT AND HARD TO MOLD PRIOR TO USE. SHE USED THE PRODUCT, AND IT DID NOT PERFORM FOR HER AS A RESULT OF IT BEING DRIED OUT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633042 ↗
• MalfunctionMar 1, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT SIX WAFERS WERE DRIED OUT AND HARD TO MOLD PRIOR TO USE. SHE USED THE PRODUCT, AND IT DID NOT PERFORM FOR HER AS A RESULT OF IT BEING DRIED OUT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633037 ↗
• MalfunctionMar 1, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT SIX WAFERS WERE DRIED OUT AND HARD TO MOLD PRIOR TO USE. SHE USED THE PRODUCT, AND IT DID NOT PERFORM FOR HER AS A RESULT OF IT BEING DRIED OUT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633026 ↗
• MalfunctionMar 1, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT SIX WAFERS WERE DRIED OUT AND HARD TO MOLD PRIOR TO USE. SHE USED THE PRODUCT, AND IT DID NOT PERFORM FOR HER AS A RESULT OF IT BEING DRIED OUT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13633023 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13555029 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13554632 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13554494 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13554303 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13554173 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13554171 ↗
• MalfunctionFeb 17, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THIS EMDR IS FOR AN ADDITIONAL UNKNOWN QUANTITY OF AFFECTED WAFERS FROM THE SAME UNKNOWN MARKET UNIT WITH UNKNOWN LOT. THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13553926 ↗
• MalfunctionFeb 15, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13533393 ↗
• MalfunctionFeb 15, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13533389 ↗
• MalfunctionFeb 15, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13533388 ↗
• MalfunctionFeb 15, 2022Material Too Rigid or Stiff; Positioning Problem; Material Too Rigid or Stiff; Positioning Problem

  THE CONSUMER'S DAUGHTER SUSPECTED THAT SIX OR SO MOLDABLE WAFERS WERE STIFFER AND MORE DIFFICULT TO MOLD OUT OF UNKNOWN NUMBER OF BOXES WITH UNKNOWN LOT. DAUGHTER WAS NOT CURRENTLY WITH END USER. SHE WAS UNSURE IF THEY CAME FROM HOME HEALTH OR THE REHABILITATION FACILITY. SHE WONDERED, IF THEY MIGHT BE OLD. HER MOTHER HAD LEAKAGE WITH ASSOCIATED SKIN IRRITATION, BUT SHE WAS UNSURE IF IT WAS RELATED TO THE WAFER CONCERN. HER WEAR TIME DECREASED NOW TO TWO DAYS WHICH WAS UP TO FOUR DAYS. HER OUTPUT COULD BE LIQUID. THE END USER CONTINUED USING THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13533387 ↗