SUR-FIT NATURA 413154Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455106158), received between Jan 19, 2022 and Mar 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2022Device Handling Problem; Device Handling Problem

  THE END USER WAS A LONG-TIME EXCLUSIVE USER OF THE PRODUCT. SHE STATED THAT APPROXIMATELY TWO WEEKS AGO SHE STARTED TO DEVELOP RED SKIN UNDER THE WAFER THAT SHE DESCRIBED AS RED PATCHES. SHE DESCRIBED AN ITCHING SENSATION WITH SKIN EXCORIATION. SHE DENIED BLISTER FORMATION OR BLEEDING. SHE REPORTED THAT SHE HAD NOT EXPERIENCED THESE SYMPTOMS IN THE PAST. SHE HAD A HISTORY OF SKIN SENSITIVITY TO ADHESIVES AND HAD TO PATCH TEST PRODUCTS WITH ADHESIVES BEFORE USING THE PRODUCT. SHE DENIED CHANGES TO HER DIET AND MEDICATIONS. SHE STATED THAT SHE HAD NOTICED SOME BULGING UNDER THE STOMA WITH SENSATIONS OF TIGHTNESS AND HAD SOUGHT OUT ADVICE FROM A SURGEON TO EVALUATE FOR POSSIBLE PARASTOMAL HERNIA. SHE WAS WEARING A CONVEX INSERT WITH THE CURRENT WAFER DUE TO A FLUSH STOMA. SHE ALSO DENIED LEAKAGE OF STOOL UNDER THE WAFER. SHE WAS SEEN BY A NURSE AND A DERMATOLOGIST FOR SKIN EVALUATION. SHE WAS TOLD BY THE DERMATOLOGIST THAT SHE HAD A COMBINATION OF SKIN ISSUES DUE TO YEAST AND SKIN SENSITIVITY TO THE PRODUCT. SHE WAS PRESCRIBED DIFLUCAN PILLS AND AN ANTIFUNGAL CREAM. SHE STATED THAT HER SKIN REACTED (UNABLE TO TOLERATE) TO AN ANTIFUNGAL POWDER. SHE REPORTED HER SKIN PREPARATION A PERIS

  Patient problems: Erythema; Fungal Infection; Hypersensitivity/Allergic reaction; Itching Sensation; Tissue Breakdown

  MAUDE report 13652238 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE WIFE OF END USER REPORTED THAT CONSUMER AD RED, OPEN AREAS UNDER APPLIANCE FOR ABOUT ONE MONTH AND HE WAS TREATED WITH ORAL CLINDAMYCIN AND DIFLUCAN AND CONDITION WAS IMPROVING. AT THAT TIME, THEY DID NOT THINK THE WAFER WAS CAUSING THE ISSUE AND THE AREAS WAS BIGGER. THEY WERE UNSURE OF THE CAUSE AND WERE CALLING FOR RECOMMENDATIONS. NO WAFER DEFECT NOTED NOTHING SEEMED WRONG WITH THE MASS. NO LEAKAGE NOTED. REVIEWED PRODUCTS IN USE: CHANGED EVERY 7-10 DAYS, USED CRUSTING TECHNIQUE WITH STOMAHESIVE POWDER AND SENSICARE BRAND WIPES WHEN REDNESS OR OPEN AREAS PRESENT. THE CONSUMER USED ZINC OXIDE IN IMMEDIATE MUCOCUTANEOUS JUNCTION AREA. EAKIN SEAL USED AND THEN BELT APPLIED. PAPER TAPE WAS USED AROUND THE EDGES OF THE WAFER. THE CONSUMER DID NOT FEEL LIKE PRESSURE WAS A COMPONENT AND DENIED A HERNIA OR BULGE IN STOMA LOCATION BUT BASED ON VIEW FROM PHOTO, THE ABDOMEN WAS VERY ROUNDED. HE STATED THAT HE DID NOT WEAR THE BELT TIGHT BUT THE OPEN AREAS APPEARED TO BE MAINLY UNDER WHERE THE WAFER FLANGE WAS LOCATED. THE PHYSICIAN DIAGNOSED HIM WITH CELLULITIS AND YEAST AND PROVIDED AN ORAL ANTIBIOTIC AND ORAL ANTI-YEAST BUT NO CULTURES OR BIOPSIES PERFORMED. DISCUSSED ALTHOUGH PHOTO

  Patient problems: Cellulitis; Fungal Infection; Tissue Breakdown

  MAUDE report 13287965 ↗