STOMAHESIVE 183910Recalls & reported problems
Convatec, Purchasing Department · Stomahesive® Paste, 2 Oz. Tube · 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 00768455150793), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- Blister1
- Erythema1
- Fungal Infection1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE END USER REPORTED TO THE RETAILER THAT THE STOMAHESIVE PASTE CAUSED PERISTOMAL BLISTER, SORES, REDNESS, AND OOZING. SHE REPORTED USE OF OTHER COMPANY¿S TWO-PIECE FLAT POUCHING SYSTEM WITH COMPANY¿S PASTE APPLIED TO MID MASS CIRCUMFERENTIALLY FOR SEVERAL YEARS WITHOUT ANY ISSUE. THE END USER WAS USING COMPANY'S PASTE WAS APPLIED WITH A BEAD IN THE MIDDLE OF THE WAFER MASS. SHE CLARIFIED THAT SHE DID NOT PLACE THE BEAD OF PASTE AT THE INNER OPENING WHERE THE BARRIER WAS SIZED TO FIT BUT SHE HAD BEEN PLACING IT IN A CIRCUMFERENTIAL BEAD TOWARDS TO MIDDLE PORTION OF THE MASS AWAY FROM THE STOMA AND BARRIER JUNCTION. SHE REPORTED THAT OVER THE MOST RECENT PAST MONTH, SHE HAD EXPERIENCED POUCH LEAKAGE, WHICH REQUIRED HER TO CHANGE THE APPLIANCE TWO TO THREE TIMES A DAY. CONSUMER FURTHER REPORTED THAT THE GLUE DID NOT SEEM TO HOLD AND THEN HE EXPERIENCED SKIN IRRITATION AND A BLISTER THAT OPENED WHICH WAS ABOUT THE SIZE OF A DIME. CONSUMER REPORTED THAT SHE DID A FOLLOW UP IN THE EMERGENCY ROOM FOR EVALUATION APPROXIMATELY ONE WEEK AGO AND SHE WAS GIVEN ONE DOSE OF INTRAVENOUS (IV) ANTIBIOTICS AND TOPICAL NYSTATIN POWDER FOR YEAST PRESENCE AND ADVISED TO FOLLOW UP WITH HER PRIMARY CAR
Patient problems: Blister; Erythema; Fungal Infection; Tissue Breakdown
MAUDE report 14984354 ↗
Other PROTECTOR, OSTOMY devices
- NATURA 404593Convatec, Purchasing Department · PROTECTOR, OSTOMY2,403 reports
- SUR-FIT NATURA 413182Convatec, Purchasing Department · PROTECTOR, OSTOMY1,202 reports
- SUR-FIT NATURA 413180Convatec, Purchasing Department · PROTECTOR, OSTOMY1,190 reports
- SUR-FIT NATURA 413179Convatec, Purchasing Department · PROTECTOR, OSTOMY1,178 reports
- SUR-FIT NATURA 413181Convatec, Purchasing Department · PROTECTOR, OSTOMY974 reports
- NATURA 411802Convatec, Purchasing Department · PROTECTOR, OSTOMY966 reports
- NATURA 404592Convatec, Purchasing Department · PROTECTOR, OSTOMY907 reports
- SUR-FIT NATURA 413183Convatec, Purchasing Department · PROTECTOR, OSTOMY773 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.