SUR-FIT NATURA 401544Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00768455103607), received between Mar 28, 2022 and Jul 23, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED THAT HE BELIEVED THERE WAS A DESIGN FLAW IN THE PRODUCT THAT NEEDED TO BE CORRECTED. IT WAS STATED THAT THE URINE BACKED UP INTO THE STOMA. THE END USER MENTIONED THAT HE WAS RECENTLY HOSPITALIZED WITH A URINARY TRACT INFECTION (UTI) AND SEPSIS, WHICH REQUIRED TREATMENT WITH CIPROFLOXACIN ANTIBIOTICS. NO PHOTO WAS AVAILABLE AT THIS TIME.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 19804114 ↗
• InjuryApr 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IN RESPONSE TO ELECTRONIC MAIL RECEIVED FROM THE DISTRIBUTOR, AN OUTBOUND CALL WAS MADE TO THE PROVIDED COMPLAINANT. THE SON OF END USER REPORTED THAT THE END USER DECEASED AS OF (B)(6) 2020. HE STATED THAT THE END USER DIED BECAUSE OF A URINARY TRACT INFECTION (UTI) FROM ESCHERICHIA COLI (E. COLI) AT AGE OF NINETY-ONE. THE END USER HAD UROSTOMY SECONDARY TO BLADDER CANCER. HIS FATHER DEVELOPED A LOT OF URINARY TRACT INFECTIONS WHILE WEARING POUCH AND HIS SON FELT THE INFECTIONS RESULTED IN END USER¿S DEATH. HE ALSO STATED THAT HIS FATHER WAS NEVER HOME FOR MORE THAN FIVE WEEKS AT A TIME DUE TO THE INFECTIONS AND END USER WAS EITHER IN A HOSPITAL OR IN A REHAB (REHABILITATION). HE ALSO MENTIONED THAT HE WAS NOT BLAMING THE PRODUCT BUT FELT THAT THERE WAS A MAJOR ISSUE REGARDING PRODUCT EDUCATION. HE STATED THAT IT WAS NOT THE POUCH FAULT AND STATED IN SOME RESPECTS IT WAS AND IN SOME RESPECTS IT WAS NOT. THE END USER CONNECTED TO A NIGHT DRAINAGE BAG AT NIGHT. NEAR THE END OF HIS FATHER'S LIFE, HIS SON REALIZED THAT WHEN HIS FATHER WENT TO BED, HIS POSITION IN THE BED RESULTED IN THE NIGHT DRAINAGE BAG TUBING BEING ABOVE THE STOMA AND THEREFORE BECAUSE THE TUBING WAS NOT IN A DEPEN

  Patient problems: Urinary Tract Infection

  MAUDE report 14101323 ↗
• MalfunctionMar 28, 2022Sharp Edges; Sharp Edges

  THE END USER¿S WIFE WHO IS ALSO THE CAREGIVER REPORTED THAT AFTER SHE HAD APPLIED THE TWO-PIECE UROSTOMY POUCH, THE END USER THOUGHT THAT THE EDGE OF THE POUCH WAS HITTING HIS SKIN, WHICH FELT ROUGH FROM ONE POUCH OUT OF SAMPLE PACK OF THREE POUCHES. SHE STATED THAT AFTER A FEW HOURS OF WEAR, THE SKIN UNDER THE WHITE MESH ON THE BODY SIDE OF THE POUCH LOOKED IRRITATED SLIGHTLY. IT DID NOT APPEAR LIKE AN ACTUAL ALLERGIC REACTION BUT JUST WHERE THE POUCH TOUCHED EXPOSED SKIN LIKE ON THE BOTTOM PART OF THE ABDOMEN DOWN TO HIS THIGH WAS RED IN COLOR AND THE END USER COMPLAINED OF SENSITIVITY ALMOST LIKE A MILD SUNBURN. SHE REMOVED WAFER AND POUCH AND THEN APPLIED THE ONE-PIECE UROSTOMY POUCH AND THEN IMMEDIATELY THE END USER SAID THAT HE WAS MUCH BETTER AND MORE COMFORTABLE. THE PRODUCT WAS USED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Burning Sensation; Erythema; Peeling

  MAUDE report 13926350 ↗