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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Pouch, Colostomy LIGHT-BOOK · MAUDE

#483 of 1000 · 2,019 reports · 1996–2026

  • BOOK 2,019 reports
  • RANK #483 of 1000
  • DEATH 1 death-typed
  • INJ 508 injury-typed
  • MALF 1,505 malfunction
  • SPAN 1996–2026
  • PEAK 2020: 381
  • PHOTO Cutaneous Tissue Adhe…

Nearest event-volume peer: Cutaneous Tissue Adhesive With Mesh (4 report gap)

Pouch, Colostomy sits #483 of 1000 among tracked device types with 2,019 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 25.2% corpus 30.4% · below corpus mean (-5.3 pp)
  • MALF 74.5% corpus 64.5% · above corpus mean (+10.0 pp)

Lead product-problem code Malposition of Device is 65% 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

reports

What this shows Pouch, Colostomy carries 2,019 MAUDE reports, ranked #483 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,505 (74.5%)
Injury 508 (25.2%)
Other 4 (0.2%)
1 (0.0%)
Death 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,599 (79.2%)
Required Intervention 306 (15.2%)
Other 75 (3.7%)
Death 28 (1.4%)
R 4 (0.2%)
Hospitalization 4 (0.2%)
O 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Malposition of Device 1,068
Sharp Edges 228
Material Too Rigid or Stiff 78
Positioning Problem 78
Adverse Event Without Identified Device or Use Problem 57
Fluid/Blood Leak 42
Difficult to Remove 26
Appropriate Term/Code Not Available 20
Device Handling Problem 5
Product Quality Problem 5
Material Disintegration 4
Material Protrusion/Extrusion 4
Material Too Soft/Flexible 4
Obstruction of Flow 4
Device Operates Differently Than Expected 3
Insufficient Information 3
Break 2
Improper or Incorrect Procedure or Method 2
Inflation Problem 2
Loss of or Failure to Bond 2

Yearly Trend

96
1996: 1
97
1997: 1
98
1998: 1
99
1999: 1
02
2002: 1
05
2005: 1
07
2007: 1
08
2008: 1
09
2009: 1
10
2010: 1
11
2011: 3
12
2012: 2
13
2013: 83
14
2014: 248
15
2015: 160
16
2016: 66
17
2017: 7
18
2018: 342
19
2019: 246
20
2020: 381
21
2021: 118
22
2022: 94
23
2023: 90
24
2024: 53
25
2025: 104
26
2026: 12

Related Entities for Pouch, Colostomy

Top Manufacturers

CONVATEC DOMINICAN REPUBLIC INC 1,275
CONVATEC DOMINICAN REPUBLIC, INC. 144
CONVATEC DOMINICAN REPUBLIC, INC 38

Event Locations

1,387 (68.7%)
I 612 (30.3%)
HOSPITAL 7 (0.3%)
NO INFORMATION 7 (0.3%)
HOME 5 (0.2%)
OTHER 1 (0.0%)

Compare CONVATEC DOMINICAN REPUBLIC INC vs CONVATEC DOMINICAN REPUBLIC, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pouch, Colostomy, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,019 here).

Cutaneous Tissue Adhesive With Mesh 2,023 Filler, Bone Void, Calcium Compound 2,026 Temporary Coronary Saphenous Vein Bypass Gr… 2,008 Handpiece, Air-Powered, Dental 2,005

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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.