2026 data FDA MAUDE openFDA FDA Class I

Collector, Urine, Powered, Non Indwelling Catheter

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.5250 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Collector LIGHT-BOOK · MAUDE

#359 of 1000 · 3,860 reports · 2016–2026

  • BOOK 3,860 reports
  • RANK #359 of 1000
  • DEATH 11 death-typed
  • INJ 1,883 injury-typed
  • MALF 1,964 malfunction
  • SPAN 2016–2026
  • PEAK 2025: 1,133
  • PHOTO Analyzer

Nearest event-volume peer: Analyzer, Pacemaker Generator Function (17 report gap)

Collector, Urine, Powered, Non Indwelling Catheter sits #359 of 1000 among tracked device types with 3,860 MAUDE reports spanning 2016–2026. 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 →

Injury-coded reports run above the device-type norm

Collector carries 48.8% INJURY-coded reports, 18.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 48.8% corpus 30.3% · above corpus mean (+18.5 pp)
  • MALF 50.9% corpus 64.8% · below corpus mean (-13.9 pp)

Lead product-problem code Decrease in Suction is 37% of coded problems · Lead manufacturer C.R. BARD INC. (COVINGTON) -1018233 accounts for 50% of manufacturer-tagged reports · Top event location is 87% of location-tagged rows .

Collector in the event-volume neighbourhood

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

reports

What this shows Collector, Urine, Powered, Non Indwelling Catheter carries 3,860 MAUDE reports, ranked #359 of 1000.

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

Event Types

Malfunction 1,964 (50.9%)
Injury 1,883 (48.8%)
Death 11 (0.3%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

Other 3,086 (77.2%)
Required Intervention 560 (14.0%)
R 101 (2.5%)
78 (2.0%)
Hospitalization 76 (1.9%)
O 62 (1.6%)
H 15 (0.4%)
Death 10 (0.3%)
D 3 (0.1%)
Disability 3 (0.1%)
L 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Decrease in Suction 1,498
Adverse Event Without Identified Device or Use Problem 836
Biocompatibility 457
Patient Device Interaction Problem 235
Increase in Suction 179
Fluid/Blood Leak 122
Device Handling Problem 120
Inadequate or Insufficient Training 113
Illegible Information 74
Overheating of Device 67
Patient-Device Incompatibility 60
Suction Failure 50
Malposition of Device 44
Use of Device Problem 44
Positioning Failure 33
Missing Information 30
Component Missing 29
Suction Problem 23
Nonstandard Device 22
Failure to Power Up 21

Yearly Trend

16
2016: 1
18
2018: 25
19
2019: 50
20
2020: 153
21
2021: 605
22
2022: 516
23
2023: 241
24
2024: 143
25
2025: 1,133
26
2026: 993

Reports rose to 1,133 in 2025, up from an average of 192 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Collector, Urine, Powered, Non Indwelling Catheter

Event Locations

3,350 (86.8%)
I 486 (12.6%)
HOSPITAL 20 (0.5%)
NO INFORMATION 4 (0.1%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Collector: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,860 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Collector 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 Collector; 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.