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2025 data FDA MAUDE openFDA

Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

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 Device LIGHT-BOOK · MAUDE

#835 of 1000 · 558 reports · 1995–2025

  • BOOK 558 reports
  • RANK #835 of 1000
  • DEATH 0 death-typed
  • INJ 16 injury-typed
  • MALF 538 malfunction
  • SPAN 1995–2025
  • PEAK 2021: 109
  • PHOTO Counter

Nearest event-volume peer: Counter, Sponge, Surgical (2 report gap)

Device, Urine Flow Rate Measuring, Non-Electrical, Disposable sits #835 of 1000 among tracked device types with 558 MAUDE reports spanning 1995–2025. 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 2.9% corpus 30.4% · below corpus mean (-27.6 pp)
  • MALF 96.4% corpus 64.5% · above corpus mean (+31.9 pp)

Lead product-problem code Detachment of Device or Device Component is 46% of coded problems · Lead manufacturer COVIDIEN accounts for 87% of manufacturer-tagged reports · Top event location I is 77% of location-tagged rows .

Device in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Device, Urine Flow Rate Measuring, Non-Electrical, Disposable carries 558 MAUDE reports, ranked #835 of 1000.

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

Event Types

Malfunction 538 (96.4%)
Injury 16 (2.9%)
Other 3 (0.5%)
1 (0.2%)

Patient Outcomes

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

532 (95.2%)
Other 14 (2.5%)
Required Intervention 12 (2.1%)
R 1 (0.2%)

Top Product Problems

Detachment of Device or Device Component 179
No Flow 67
Obstruction of Flow 22
Leak/Splash 15
Break 14
Infusion or Flow Problem 11
Device Contamination with Chemical or Other Material 7
Material Integrity Problem 7
Material Separation 7
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 7
Disconnection 6
Improper Flow or Infusion 6
Occlusion Within Device 6
Crack 5
Delivered as Unsterile Product 5
Device Operates Differently Than Expected 5
Fluid/Blood Leak 5
Fracture 5
Detachment Of Device Component 4
Restricted Flow rate 4

Yearly Trend

95
1995: 1
97
1997: 2
98
1998: 1
01
2001: 1
06
2006: 1
12
2012: 1
13
2013: 10
14
2014: 54
15
2015: 103
16
2016: 96
17
2017: 34
18
2018: 9
19
2019: 10
20
2020: 92
21
2021: 109
22
2022: 21
23
2023: 6
24
2024: 3
25
2025: 4

Related Entities for Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

Top Manufacturers

COVIDIEN 169
CARDINAL HEALTH 26

Event Locations

I 427 (76.5%)
113 (20.3%)
HOSPITAL 10 (1.8%)
NO INFORMATION 7 (1.3%)
INVALID DATA 1 (0.2%)

Compare COVIDIEN vs CARDINAL HEALTH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, 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 (558 here).

Counter, Sponge, Surgical 560 Microspheres Radionuclide 562 Chair, Adjustable, Mechanical 564 Injector, Contrast Medium, Automatic 564

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Device 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 Device; 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.