2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Bag, Urinary, Ileostomy LIGHT-BOOK · MAUDE

#845 of 1000 · 539 reports · 2000–2026

  • BOOK 539 reports
  • RANK #845 of 1000
  • DEATH 0 death-typed
  • INJ 80 injury-typed
  • MALF 459 malfunction
  • SPAN 2000–2026
  • PEAK 2018: 112
  • PHOTO Applier

Nearest event-volume peer: Applier, Staple, Surgical, (0 report gap)

Bag, Urinary, Ileostomy sits #845 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 →

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 14.8% corpus 30.4% · below corpus mean (-15.6 pp)
  • MALF 85.2% corpus 64.5% · above corpus mean (+20.7 pp)

Lead product-problem code Malposition of Device is 85% 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

reports

What this shows Bag, Urinary, Ileostomy carries 539 MAUDE reports, ranked #845 of 1000.

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

Event Types

Malfunction 459 (85.2%)
Injury 80 (14.8%)

Patient Outcomes

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

479 (87.9%)
Required Intervention 45 (8.3%)
Other 8 (1.5%)
Hospitalization 7 (1.3%)
R 5 (0.9%)
L 1 (0.2%)

Top Product Problems

Malposition of Device 370
Adverse Event Without Identified Device or Use Problem 12
Material Disintegration 12
Fluid/Blood Leak 10
Positioning Problem 9
Sharp Edges 9
Insufficient Information 3
Complete Blockage 2
Delamination 1
Device Contamination with Chemical or Other Material 1
Improper or Incorrect Procedure or Method 1
Leak/Splash 1
Material Erosion 1
Material Separation 1
Use of Device Problem 1

Yearly Trend

00
2000: 1
09
2009: 1
10
2010: 2
13
2013: 4
14
2014: 88
15
2015: 27
16
2016: 9
18
2018: 112
19
2019: 93
20
2020: 89
21
2021: 2
22
2022: 10
23
2023: 28
24
2024: 59
25
2025: 13
26
2026: 1

Related Entities for Bag, Urinary, Ileostomy

Event Locations

330 (61.2%)
I 206 (38.2%)
NO INFORMATION 2 (0.4%)
HOME 1 (0.2%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Bag, Urinary, Ileostomy, 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 (539 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

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.