SUR-FIT NATURA 125273Recalls & reported problems

Convatec, Purchasing Department · SUR-FIT Natura® Stomahesive® Flexible Pre-Cut 4" X 4" Wafer Tan 1 1/4 Stoma, Flange Size 1 3/4 · Class 1

All models of SUR-FIT NATURA (43)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Convatec SUR-FIT Natura pre-cut ostomy skin barrier is a wafer worn around a stoma. Most of the 64 reports describe the pre-cut opening sitting off-center or too close to the flange, so the barrier would not stick or fit properly, along with some leaking and positioning issues. There are 2 injuries and no deaths, and no recalls name this device. All 38 reports came in the last 12 months, with none in the prior 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 64
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00768455101863), received between Jan 10, 2019 and Nov 18, 2025 — classified as 2 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (62 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Malposition of Device62
Fluid/Blood Leak4
Device Handling Problem2
Positioning Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions49
No Consequences Or Impact To Patient13
Urinary Tract Infection2

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580358 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580357 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580356 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580355 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580354 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580263 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580262 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580259 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580249 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580247 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580245 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580244 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580243 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580242 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580241 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580240 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580239 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580238 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580237 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY-EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580236 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580235 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580234 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580233 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580232 ↗
MalfunctionNov 18, 2025Malposition of Device; Malposition of Device
THE CONSUMER REPORTED THAT THE PRECUT OPENING IN THE SKIN BARRIER WAS FAR OFF-CENTER, MAKING IT TOO CLOSE TO THE FLANGE. DUE TO THIS DEFECT, THEY WERE UNABLE TO APPLY THE SKIN BARRIERS PROPERLY. THE ISSUE WAS IDENTIFIED VISUALLY BEFORE ANY ATTEMPT TO USE THE PRODUCT. A TOTAL OF THIRTY EIGHT SKIN BARRIERS FROM FOUR MARKET UNITS WERE AFFECTED. THE CONSUMER DID NOT USE THE PRODUCTS AND REQUESTED REPLACEMENTS, WHICH WERE PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580231 ↗

Device details

UDI-DI	`00768455101863`
Brand	SUR-FIT NATURA
Model	125273
Company	Convatec, Purchasing Department
Product code	EXE · Protector, Ostomy
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 7, 2022

Device type (GMDN): Intestinal ostomy base plate, flat

A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. This is a single-use device.

Other Protector, Ostomy devices

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SUR-FIT NATURA 413180
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SUR-FIT NATURA 413179
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NATURA 404592
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All Protector, Ostomy devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page