ESTEEM 423727Recalls & reported problems
Convatec, Purchasing Department · N/A · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455204762), received between Jul 29, 2025 and Jul 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sharp Edges” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 6, 2026Open, Classified
Urostomy Pouches may leak from cap during use.
Z-2986-2026 · Root cause: Material/Component Contamination · FDA record ↗
Most reported problems
Device problems
- Sharp Edges1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Sharp Edges; Sharp Edges
THE CUSTOMER REPORTED BLEEDING FROM THE STOMA THAT POOLED IN THE POUCH AND TURNED THE URINE RED. HE MENTIONED THAT THE NURSE HAD CUT THE POUCH TO THE LAST LINE, AND UPON APPLICATION, IT FELT SHARP, ALTHOUGH NO EXPOSED PLASTIC WAS SEEN. THERE WAS NO VISIBLE LACERATION ON THE STOMA, AND THE BLEEDING HAD RESOLVED. THE CUSTOMER DID NOT RECALL ANY TRAUMA OR INCIDENT THAT COULD HAVE CAUSED THE BLEEDING. NO PHOTO WAS AVAILABLE. THE INCIDENT DID NOT REQUIRE HOSPITALIZATION OR PRESCRIPTION MEDICATION, AND THE PATIENT CONTINUED USING THE PRODUCT. THE EVENT RESULTED IN BLEEDING BUT NO TISSUE DAMAGE OR SKIN IRRITATION. THE PATIENT HAS A UROSTOMY, AND NO LAB RESULTS OR CURRENT MEDICATIONS WERE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22641280 ↗
Other BAG, URINARY, ILEOSTOMY devices
- ESTEEM 423717Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423705Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423726Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423704Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423714Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423716Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423722Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423725Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.