2026 data FDA MAUDE openFDA FDA Class II

Urinometer, Electrical

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 II (moderate risk, special controls required), regulated under 21 CFR §876.1800 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Urinometer, Electrical LIGHT-BOOK · MAUDE

#923 of 1000 · 464 reports · 2017–2026

  • BOOK 464 reports
  • RANK #923 of 1000
  • DEATH 0 death-typed
  • INJ 3 injury-typed
  • MALF 461 malfunction
  • SPAN 2017–2026
  • PEAK 2022: 226
  • PHOTO Connector, Airway

Nearest event-volume peer: Connector, Airway (Extension) (2 report gap)

Urinometer, Electrical sits #923 of 1000 among tracked device types with 464 MAUDE reports spanning 2017–2026. 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

Urinometer, Electrical carries 99.4% MALFUNCTION-coded reports, 34.5pp 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 0.6% corpus 30.3% · below corpus mean (-29.6 pp)
  • MALF 99.4% corpus 64.8% · above corpus mean (+34.5 pp)

Lead product-problem code Volume Accuracy Problem is 21% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 91% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .

Urinometer, Electrical in the event-volume neighbourhood

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

reports

What this shows Urinometer, Electrical carries 464 MAUDE reports, ranked #923 of 1000.

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

Event Types

Malfunction 461 (99.4%)
Injury 3 (0.6%)

Patient Outcomes

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

Other 378 (81.5%)
81 (17.5%)
Required Intervention 5 (1.1%)

Top Product Problems

Volume Accuracy Problem 103
Device Sensing Problem 92
Display or Visual Feedback Problem 50
Component Misassembled 34
Computer Software Problem 32
Operating System Becomes Nonfunctional 24
Incorrect, Inadequate or Imprecise Result or Readings 21
Restricted Flow rate 20
Computer Operating System Problem 17
Erratic or Intermittent Display 14
Break 12
Circuit Failure 11
Failure to Calibrate 10
Incorrect Measurement 10
Defective Component 9
Use of Device Problem 9
Material Fragmentation 8
Device Handling Problem 7
Intermittent Loss of Power 7
Failure to Power Up 6

Yearly Trend

17
2017: 29
18
2018: 16
19
2019: 18
20
2020: 13
21
2021: 33
22
2022: 226
23
2023: 97
24
2024: 13
25
2025: 16
26
2026: 3

Reports fell to 16 in 2025, down from an average of 55 in the two years before.

Related Entities for Urinometer, Electrical

Event Locations

378 (81.5%)
I 82 (17.7%)
HOSPITAL 4 (0.9%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs C.R. BARD INC. (COVINGTON) -1018233 →

Nationwide devices with a comparable report-volume footprint

Urinometer, Electrical 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 (464 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 Urinometer, Electrical 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 Urinometer, Electrical; 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.