SUR-FIT NATURA 125271Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00768455101849), received between Dec 2, 2020 and Jan 23, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Malposition of Device; Malposition of Device

  THE CONSUMER REPORTED THAT FIVE WAFERS FROM ONE MARKET UNIT (MU) HAD OFF CENTERED STARTER HOLE ISSUE. THE CONSUMER ALSO STATED THAT THE OFF CENTERED HOLES WERE IN VARYING DEGREES LIKE SOME WERE MILD AND SOME WERE MORE SEVERE. THE END USER ALSO REPORTED THAT SHE WAS ABLE TO WEAR SOME OF THE AFFECTED WAFERS, BUT WEAR TIME DECLINED FROM TWO DAYS TO LESS THAN ONE DAY. SHE STATED THAT ONE OF THE AFFECTED WAFERS WERE SO BAD THAT SHE WAS UNABLE TO ATTACH IT TO THE COMPANY¿S KNOWN POUCH. ALSO, MENTIONED THAT ONE DAY SHE HAD TO CHANGE THE PRODUCT THREE TIMES DUE TO THE OFF CENTERED HOLES. SHE STATED THAT EMOTIONALLY SHE WAS VERY UPSET AND HAD LOST FAITH IN THE PRODUCT. THE PRODUCT WAS USED BY PATIENT. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215766 ↗
• MalfunctionJan 23, 2025Malposition of Device; Malposition of Device

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215764 ↗
• MalfunctionJan 23, 2025Malposition of Device; Malposition of Device

  THE CONSUMER REPORTED THAT FIVE WAFERS FROM ONE MARKET UNIT (MU) HAD OFF CENTERED STARTER HOLE ISSUE. THE CONSUMER ALSO STATED THAT THE OFF CENTERED HOLES WERE IN VARYING DEGREES LIKE SOME WERE MILD AND SOME WERE MORE SEVERE. THE END USER ALSO REPORTED THAT SHE WAS ABLE TO WEAR SOME OF THE AFFECTED WAFERS, BUT WEAR TIME DECLINED FROM TWO DAYS TO LESS THAN ONE DAY. SHE STATED THAT ONE OF THE AFFECTED WAFERS WERE SO BAD THAT SHE WAS UNABLE TO ATTACH IT TO THE COMPANY¿S KNOWN POUCH. ALSO, MENTIONED THAT ONE DAY SHE HAD TO CHANGE THE PRODUCT THREE TIMES DUE TO THE OFF CENTERED HOLES. SHE STATED THAT EMOTIONALLY SHE WAS VERY UPSET AND HAD LOST FAITH IN THE PRODUCT. THE PRODUCT WAS USED BY PATIENT. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215763 ↗
• MalfunctionJan 23, 2025Malposition of Device; Malposition of Device

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215762 ↗
• MalfunctionJan 23, 2025Malposition of Device; Malposition of Device

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215761 ↗
• MalfunctionNov 5, 2024Sharp Edges; Sharp Edges

  THE END USER REPORTED THAT HE EXPERIENCED RED BUMPS ALONG PERIPHERY OF TAPE COLLAR EDGE. HE NORMALLY USED OTHER COMPANY¿S PRODUCTS AND RECENTLY SWITCHED TO OUR COMPANY¿S PRODUCT DUE TO POUCH OPTION PREFERENCE. HE HAD NOT PREVIOUSLY TRIALED OUR COMPANY¿S PRODUCT. HE STATED HE DEVELOPED RED BUMPS ALONG THE PERIPHERY OF THE TAPE COLLAR. HE ALSO, STATED THAT THE TAPE EDGES FELT ROUGH. THERE WAS NO IRRITATION UNDER THE TAPE OR MASS. HE APPLIED THE WAFER IN A SEMI-RECLINED POSITION BEFORE SITTING UP. HE USED THE COMPANY¿S BARRIER WIPES PRIOR TO APPLICATION AND ALLOWED IT TO DRY. AFTER REMOVING THE SKIN BARRIER, HE APPLIED HIS USUAL OTHER COMPANY¿S PRODUCT, AND THE BUMPS WERE RESOLVED BY THE NEXT CHANGE THREE TO FOUR DAYS LATER. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation; Urticaria

  MAUDE report 20607922 ↗
• MalfunctionFeb 20, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT STARTER HOLE OF PRE-CUT WAFER WAS OVAL. THE PRODUCT WAS NOT USED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737402 ↗
• MalfunctionFeb 20, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT STARTER HOLE OF PRE-CUT WAFER WAS OVAL. THE PRODUCT WAS NOT USED. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737401 ↗
• MalfunctionDec 2, 2020Malposition 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 10933970 ↗