Skip to content

SUR-FIT NATURA 125266Recalls & reported problems

Convatec, Purchasing Department · SUR-FIT Natura® Stomahesive® Flexible 5" X 5" Wafer Tan 2 3/4 · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455101795), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Handling Problem1

Patient problems

  • Abrasion1
  • Blister1
  • Hemorrhage/Blood Loss/Bleeding1
  • Tissue Breakdown1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 31, 2022Device Handling Problem; Device Handling Problem

    THE END USER REPORTED THAT SHE CUT THE BARRIER ALL THE WAY TO THE FLANGE BUT THE PRODUCT WAS STILL NOT LARGE ENOUGH FOR HER STOMA. SHE DESCRIBED THAT IT COVERED UP PART OF THE STOMA AND RUBBED THE STOMA THAT CAUSED BLISTERS TO BLEED. SHE HAD A LARGE PARASTOMAL HERNIA (LARGER THAN SOFTBALL-SIZED) AND ALSO WEARS A HERNIA SUPPORT BELT. THE RING ON THE BELT ALSO COVERED UP PART OF THE STOMA AND RUBBED ON THE IT. SHE ALSO STATED THAT SHE SAW PHYSICIAN OVER A YEAR AGO FOR THESE CONCERNS AND THE AREAS THAT SHE CALLED BLISTERS WERE CAUTERIZED BUT NO DIAGNOSIS WAS PROVIDED. SHE ALSO ADVISED THAT A CREAM WAS RECOMMENDED BUT THE PHARMACY DIDN'T HAD IT AND SHE NEVER GOT IT. THE END USER REPORTED THAT SHE WAS ADVISED THAT LARGER PRODUCTS WERE AVAILABLE. ALSO BASED ON INFORMATION PROVIDED, SHE WAS ADVISED THAT A ONE PIECE APPLIANCE WOULD OFFER MORE FLEXIBILITY AND CONFORMITY TO THE ABDOMEN AND SUGGESTED TWO OTHER COMPANY DEVICES. SHE AGREED TO TRIAL AND SAMPLES WERE SENT. THE END USER CONTINUED TO USE THE PRODUCT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Patient problems: Abrasion; Blister; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

    MAUDE report 13391262 ↗

Other PROTECTOR, OSTOMY devices

All PROTECTOR, OSTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.