SUR-FIT NATURA 125265Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00768455101788), received between Mar 8, 2019 and May 30, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Sharp Edges; Sharp Edges

  THE END USER EMAILED ABOUT AN ISSUE WITH THE COMPANY'S KNOWN PRODUCT. SHE STATED THAT THERE WERE SHARP EDGES WHERE THE TAPE COLLAR AND FLANGE RING CONNECTED. THIS HAD HAPPENED WITH FIVE UNITS IN ONE BOX. SHE HAD TO FILE AND TRIM THE SHARP EDGES. THE PRODUCT WAS USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112149 ↗
• MalfunctionMay 30, 2025Sharp Edges; Sharp Edges

  THE END USER EMAILED ABOUT AN ISSUE WITH THE COMPANY'S KNOWN PRODUCT. SHE STATED THAT THERE WERE SHARP EDGES WHERE THE TAPE COLLAR AND FLANGE RING CONNECTED. THIS HAD HAPPENED WITH FIVE UNITS IN ONE BOX. SHE HAD TO FILE AND TRIM THE SHARP EDGES. THE PRODUCT WAS USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112145 ↗
• MalfunctionMay 30, 2025Sharp Edges; Sharp Edges

  THE END USER EMAILED ABOUT AN ISSUE WITH THE COMPANY'S KNOWN PRODUCT. SHE STATED THAT THERE WERE SHARP EDGES WHERE THE TAPE COLLAR AND FLANGE RING CONNECTED. THIS HAD HAPPENED WITH FIVE UNITS IN ONE BOX. SHE HAD TO FILE AND TRIM THE SHARP EDGES. THE PRODUCT WAS USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112144 ↗
• MalfunctionMay 30, 2025Sharp Edges; Sharp Edges

  THE END USER EMAILED ABOUT AN ISSUE WITH THE COMPANY'S KNOWN PRODUCT. SHE STATED THAT THERE WERE SHARP EDGES WHERE THE TAPE COLLAR AND FLANGE RING CONNECTED. THIS HAD HAPPENED WITH FIVE UNITS IN ONE BOX. SHE HAD TO FILE AND TRIM THE SHARP EDGES. THE PRODUCT WAS USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112143 ↗
• MalfunctionMay 30, 2025Sharp Edges; Sharp Edges

  THE END USER EMAILED ABOUT AN ISSUE WITH THE COMPANY'S KNOWN PRODUCT. SHE STATED THAT THERE WERE SHARP EDGES WHERE THE TAPE COLLAR AND FLANGE RING CONNECTED. THIS HAD HAPPENED WITH FIVE UNITS IN ONE BOX. SHE HAD TO FILE AND TRIM THE SHARP EDGES. THE PRODUCT WAS USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112142 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem; Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem

  THE CUSTOMER STATED THAT SHE HAS USED FOUR APPLIANCES OUT OF TEN SO FAR AND FOUND THAT THE SKIRT AROUND THE FLANGE RING WAS SHARP AND LIFTED OFF THE SKIN BARRIER. SHE STATED THAT IT LIFTED OFF AFTER FOUR DAYS AND THEN, CHANGED IT TO THREE IN ONE NIGHT AND AFTERWARDS, EXPERIENCED LEAKAGE AS WELL. THE CUSTOMER HAD A LEAKAGE FROM UNDER THE FLANGE RING SO SHE HAD PUT HER HAND THERE AND FOUND THE AREA WAS SHARP. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400864 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem; Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem

  THE CUSTOMER STATED THAT SHE HAS USED FOUR APPLIANCES OUT OF TEN SO FAR AND FOUND THAT THE SKIRT AROUND THE FLANGE RING WAS SHARP AND LIFTED OFF THE SKIN BARRIER. SHE STATED THAT IT LIFTED OFF AFTER FOUR DAYS AND THEN, CHANGED IT TO THREE IN ONE NIGHT AND AFTERWARDS, EXPERIENCED LEAKAGE AS WELL. THE CUSTOMER HAD A LEAKAGE FROM UNDER THE FLANGE RING SO SHE HAD PUT HER HAND THERE AND FOUND THE AREA WAS SHARP. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400862 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem; Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem

  THE CUSTOMER STATED THAT SHE HAS USED FOUR APPLIANCES OUT OF TEN SO FAR AND FOUND THAT THE SKIRT AROUND THE FLANGE RING WAS SHARP AND LIFTED OFF THE SKIN BARRIER. SHE STATED THAT IT LIFTED OFF AFTER FOUR DAYS AND THEN, CHANGED IT TO THREE IN ONE NIGHT AND AFTERWARDS, EXPERIENCED LEAKAGE AS WELL. THE CUSTOMER HAD A LEAKAGE FROM UNDER THE FLANGE RING SO SHE HAD PUT HER HAND THERE AND FOUND THE AREA WAS SHARP. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400860 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem; Fluid/Blood Leak; Material Separation; Activation, Positioning or Separation Problem; Positioning Problem; Sharp Edges; Separation Problem

  THE CUSTOMER STATED THAT SHE HAS USED FOUR APPLIANCES OUT OF TEN SO FAR AND FOUND THAT THE SKIRT AROUND THE FLANGE RING WAS SHARP AND LIFTED OFF THE SKIN BARRIER. SHE STATED THAT IT LIFTED OFF AFTER FOUR DAYS AND THEN, CHANGED IT TO THREE IN ONE NIGHT AND AFTERWARDS, EXPERIENCED LEAKAGE AS WELL. THE CUSTOMER HAD A LEAKAGE FROM UNDER THE FLANGE RING SO SHE HAD PUT HER HAND THERE AND FOUND THE AREA WAS SHARP. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400858 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED THAT APPROXIMATELY 4-5 MONTHS AGO, HE UNKNOWINGLY CUT HIS WAFER/SKIN BARRIER OPENING TOO SMALL FOR HIS STOMA PER HIS LOCAL OSTOMY NURSE. HIS STOMA SIZE HAD CHANGED FROM 25MM TO 45MM. AS A RESULT, HE DEVELOPED BLEEDING WITH PETECHIAE FROM 3-6 O' CLOCK ON THE STOMA MUCOSA. REPORTEDLY, HE DID NOT REPORT A CUT OR OTHER INJURY ON THE STOMA. ALSO, LOCAL OSTOMY NURSE WAS USING SILVER NITRATE TO CAUTERIZE THE BLEEDING FOR SEVERAL WEEKS, AND EVEN AFTER SIZING THE WAFER OPENING CORRECTLY, THE BLEEDING PERSISTED. HE VISITED OSTOMY NURSE 1 MONTH AGO. HE ALSO REPORTED THAT OCCASIONAL BLEEDING THROUGHOUT THE DAY WAS VISIBLE IN POUCH, NOT ASSOCIATED WITH ANY ACTIVITY. THE BLEEDING SOMETIMES LASTED FOR AN HOUR AND STOPPED WITH PRESSURE. THE END USER ALSO STATED THAT HE DOES NOT WEAR AN OSTOMY WRAP OR BINDER AND DOES NOT HAVE HIS WAIST BAND OR SEAT BELT OVER THE STOMA AT ANY TIME. HE STATED THAT HE ALSO HAD A GRAPEFRUIT-SIZED BULGE JUST BELOW THE STOMA. HIS USUAL WEAR TIME WAS 2-3 DAYS. HE REPORTED THAT HE DID NOT PREFERRED USE OF ADHESIVE REMOVER, BUT HE USUALLY REMOVED HIS WAFER, VERY CAREFULLY IN THE SHOWER WITH IVORY SOAP AND KEPT THE SHOWER HEAD AT A GENTLE SETTING. HE AL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 12663110 ↗
• MalfunctionMar 8, 2019Sharp Edges; Sharp Edges

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

  Patient problems: Blood Loss; Laceration(s)

  MAUDE report 8403518 ↗