SUR-FIT NATURA 401933Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00768455104208), received between Jan 25, 2024 and Jan 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Abrasion; Skin Inflammation/ Irritation

  MAUDE report 18579213 ↗
• MalfunctionJan 25, 2024Sharp Edges; Sharp Edges

  THE END USER REPORTED THAT POUCH FLANGE WAS JAGGED AND HAD PIECES OF PLASTIC STICKING OUT. IT WAS NOT SMOOTH. SHE TRIED ONE, BUT IT LEAKED. SHE CLARIFIED THAT THE FLANGE GROOVE WHERE THE WAFER INSERTED WAS NOT CUT CORRECTLY. IN HER OPINION, THE MACHINERY USED DID NOT LOOK LIKE IT WAS SHARP ENOUGH TO CUT IT DEEP ENOUGH OR PROPERLY. SHE DESCRIBED IT AS A "BAD HOLE PUNCH". SHE WORE ONE POUCH WHERE THE PLASTIC RUBBED AGAINST HER STOMA BECAUSE THERE WAS AN OUTWARD PROJECTION OF PLASTIC. SHE FELT THAT IT IRRITATED HER STOMA SUPERFICIALLY BUT DID NOT REPORT BLEEDING OR ANY SIGNS OF ACTUAL INJURY. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion; Skin Inflammation/ Irritation

  MAUDE report 18579210 ↗
• MalfunctionJan 25, 2024Sharp Edges; Sharp Edges

  THIS EMDR IS BEING SUBMITTED FOR AN ADDITIONAL UNKNOWN QUANTITY OF AFFECTED PRODUCTS. THE END USER REPORTED THAT POUCH FLANGE WAS JAGGED AND HAD PIECES OF PLASTIC STICKING OUT. IT WAS NOT SMOOTH. SHE TRIED ONE, BUT IT LEAKED. SHE CLARIFIED THAT THE FLANGE GROOVE WHERE THE WAFER INSERTED WAS NOT CUT CORRECTLY. IN HER OPINION, THE MACHINERY USED DID NOT LOOK LIKE IT WAS SHARP ENOUGH TO CUT IT DEEP ENOUGH OR PROPERLY. SHE DESCRIBED IT AS A "BAD HOLE PUNCH". SHE WORE ONE POUCH WHERE THE PLASTIC RUBBED AGAINST HER STOMA BECAUSE THERE WAS AN OUTWARD PROJECTION OF PLASTIC. SHE FELT THAT IT IRRITATED HER STOMA SUPERFICIALLY BUT DID NOT REPORT BLEEDING OR ANY SIGNS OF ACTUAL INJURY. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Abrasion; Skin Inflammation/ Irritation

  MAUDE report 18579209 ↗