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.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §876.1800 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Device LIGHT-BOOK · MAUDE
#854 of 1000 · 557 reports · 1995–2025
- BOOK 557 reports
- RANK #854 of 1000
- DEATH 0 death-typed
- INJ 16 injury-typed
- MALF 537 malfunction
- SPAN 1995–2025
- PEAK 2021: 109
- PHOTO Instrument
Nearest event-volume peer: Instrument, Ent Manual Surgical (0 report gap)
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable sits #854 of 1000 among tracked device types with 557 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 →
Malfunction reports run above the device-type norm
Device carries 96.4% MALFUNCTION-coded reports, 31.6pp 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 2.9% corpus 30.3% · below corpus mean (-27.4 pp)
- MALF 96.4% corpus 64.8% · above corpus mean (+31.6 pp)
Lead product-problem code Detachment of Device or Device Component is 34% of coded problems · Lead manufacturer COVIDIEN accounts for 85% 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
- Needle
Needle, Suturing, Disposable
559 reports
- Device (this)
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
557 reports
- Instrument
Instrument, Ent Manual Surgical
557 reports
- Prosthesis
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
555 reports
- Chair
Chair, Positioning, Electric
554 reports
- Cup, Menstrual
Cup, Menstrual
553 reports
What this shows Device, Urine Flow Rate Measuring, Non-Electrical, Disposable carries 557 MAUDE reports, ranked #854 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 fell to 3 in 2024, down from an average of 14 in the two years before.
Related Entities for Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Device 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 (557 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
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.