Bag, Urinary, Ileostomy
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.5900 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Bag, Urinary, Ileostomy LIGHT-BOOK · MAUDE
#866 of 1000 · 539 reports · 2000–2026
- BOOK 539 reports
- RANK #866 of 1000
- DEATH 0 death-typed
- INJ 80 injury-typed
- MALF 459 malfunction
- SPAN 2000–2026
- PEAK 2018: 112
- PHOTO Container
Nearest event-volume peer: Container, Specimen, Sterile (0 report gap)
Bag, Urinary, Ileostomy sits #866 of 1000 among tracked device types with 539 MAUDE reports spanning 2000–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Bag, Urinary, Ileostomy carries 85.2% MALFUNCTION-coded reports, 20.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 14.8% corpus 30.3% · below corpus mean (-15.5 pp)
- MALF 85.2% corpus 64.8% · above corpus mean (+20.3 pp)
Lead product-problem code Malposition of Device is 67% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 97% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .
Bag, Urinary, Ileostomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Collector
Collector, Ostomy
543 reports
- Insufflator
Insufflator, Hysteroscopic
541 reports
- Insufflator
Insufflator, Automatic Carbon-Dioxide For Endoscope
540 reports
- Bag (this)
Bag, Urinary, Ileostomy
539 reports
- Container
Container, Specimen, Sterile
539 reports
- Accessories
Accessories, Pump, Infusion
537 reports
What this shows Bag, Urinary, Ileostomy carries 539 MAUDE reports, ranked #866 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 13 in 2025, down from an average of 44 in the two years before.
Related Entities for Bag, Urinary, Ileostomy
Top Manufacturers
Event Locations
Compare CONVATEC DOMINICAN REPUBLIC INC vs CONVATEC DOMINICAN REPUBLIC, INC. →
Nationwide devices with a comparable report-volume footprint
Bag, Urinary, Ileostomy carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (539 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Bag, Urinary, Ileostomy are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Bag, Urinary, Ileostomy; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.