ESTEEM 423690Recalls & reported problems
Convatec, Purchasing Department · N/A · 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 00768455204397), received between Sep 23, 2024 and Sep 23, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Embolism/Embolus1
- Nodule1
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE END USER REPORTED AN INCIDENT THAT, WHEN SHE REMOVED A SAMPLE AND DISCOVERED A BLACK SPOT/NODULE AT THE TOP OF HER STOMA, WHICH TURNED GREEN WITHIN TWO DAYS. ALTHOUGH IT GOT SMALLER, HER PHYSICIAN EVALUATED IT AND DESCRIBED IT AS LOOKING LIKE AN EMBOLUS. THE END USER SURMISED THAT SHE HAD ACCIDENTALLY COVERED THE TOP PART OF THE STOMA WITH THE BARRIER. SHE WAS UNSURE OF THE EXACT DURATION THE POUCH WAS IN PLACE BUT ESTIMATED IT WAS LESS THAN ONE DAY. SHE NOTED THAT HER STOMA HAS AN UNEVEN PROFILE, WITH A SLIGHTLY BUDDED TOP AND A SLIGHTLY RETRACTED DISTAL END. SHE STATED SHE HAS ALSO USED TO PRECUT AND TWO-PIECE PRODUCTS. SHE HAD TO CUT THIS ONE. SHE BELIEVED SHE CUT IT TO THE CORRECT SIZE BUT MADE AN APPLICATION ERROR. NO ISSUES WERE NOTICED WHILE WEARING THE PRODUCT. THE END USER IDENTIFIED THIS AS "USER ERROR" AND CONFIRMED NO SHARP EDGES WERE SEEN. SHE HAD USED A TEN TO FORTY-FIVE MILLIMETERS (MM) SIZE RANGE FOR CUT-TO-FIT AND CUT IT TO TWENTY-FIVE MM. THE PATIENT HAD COLOSTOMY, AND HER STOMA SIZE WAS TWENTY-FIVE MM WITH UNEVEN LEVEL OF PROTRUSION. NO MEDICAL INTERVENTION OR DIAGNOSTICS WERE REQUIRED. SHE APPLIED A NEW POUCH. SHE COMMITTED TO TAKING GREATER CARE WITH FUTURE
Patient problems: Embolism/Embolus; Nodule; Skin Discoloration
MAUDE report 20276798 ↗
Other Pouch, colostomy devices
- ACTIVELIFE 175777Convatec, Purchasing Department · POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175778Convatec, Purchasing Department · POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175779Convatec, Purchasing Department · POUCH, COLOSTOMY39 reports
- ESTEEM SYNERGY+ 416779Convatec, Purchasing Department · POUCH, COLOSTOMY30 reports
- ACTIVELIFE 175782Convatec, Purchasing Department · POUCH, COLOSTOMY19 reports
- FLEXI-SEAL 418000Convatec, Purchasing Department · POUCH, COLOSTOMY16 reports
- ACTIVELIFE 175780Convatec, Purchasing Department · POUCH, COLOSTOMY10 reports
- ACTIVELIFE 175784Convatec, Purchasing Department · POUCH, COLOSTOMY5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.