Pouch, Colostomy
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 Pouch, Colostomy LIGHT-BOOK · MAUDE
#500 of 1000 · 2,020 reports · 1996–2026
- BOOK 2,020 reports
- RANK #500 of 1000
- DEATH 1 death-typed
- INJ 509 injury-typed
- MALF 1,505 malfunction
- SPAN 1996–2026
- PEAK 2020: 381
- PHOTO Valve, Pulmonary
Nearest event-volume peer: Valve, Pulmonary (4 report gap)
Pouch, Colostomy sits #500 of 1000 among tracked device types with 2,020 MAUDE reports spanning 1996–2026. 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
Pouch, Colostomy carries 74.5% MALFUNCTION-coded reports, 9.7pp 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 25.2% corpus 30.3% · below corpus mean (-5.1 pp)
- MALF 74.5% corpus 64.8% · above corpus mean (+9.7 pp)
Lead product-problem code Malposition of Device is 51% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 88% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .
Pouch, Colostomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Temporary Cor…
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
2,032 reports
- Tricuspid Val…
Tricuspid Valve Repair Device, Percutaneously Delivered
2,028 reports
- Apparatus
Apparatus, Suction, Ward Use, Portable, Ac-Powered
2,026 reports
- Pouch (this)
Pouch, Colostomy
2,020 reports
- Valve
Valve, Pulmonary
2,016 reports
- Electrode
Electrode, Pacemaker, Temporary
2,012 reports
What this shows Pouch, Colostomy carries 2,020 MAUDE reports, ranked #500 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 rose to 104 in 2025, up from an average of 72 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Pouch, Colostomy
Top Manufacturers
Event Locations
Compare CONVATEC DOMINICAN REPUBLIC INC vs CONVATEC DOMINICAN REPUBLIC, INC. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pouch, Colostomy: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,020 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pouch, Colostomy 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 Pouch, Colostomy; 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.