What are FDA adverse event reports for Catheter, Urethral?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Catheter, Urethral, there are 2,528 total reports including 4 death reports and 663 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Catheter, Urethral?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Catheter, Urethral

Name: Catheter, Urethral - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Catheter, Urethral LIGHT-BOOK · MAUDE

#432 of 1000 · 2,528 reports · 1994–2026

BOOK 2,528 reports
RANK #432 of 1000
DEATH 4 death-typed
INJ 663 injury-typed
MALF 1,854 malfunction
SPAN 1994–2026
PEAK 2024: 468
PHOTO Handpiece

Nearest event-volume peer: Handpiece, Contra- And Right-Angle Attachment, Dental (5 report gap)

Catheter, Urethral sits #432 of 1000 among tracked device types with 2,528 MAUDE reports spanning 1994–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 26.2% corpus 30.4% · below corpus mean (-4.2 pp)
MALF 73.3% corpus 64.5% · above corpus mean (+8.8 pp)

Lead product-problem code Tear, Rip or Hole in Device Packaging is 19% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 50% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Catheter (this)

2,528
Handpiece

2,523
Real Time Nuc…

2,522
Aid, Transfer

2,510
System

2,503
Catheter

2,498

What this shows Catheter, Urethral carries 2,528 MAUDE reports, ranked #432 of 1000.

Event Types

Malfunction 1,854 (73.3%)

Injury 663 (26.2%)

Other 6 (0.2%)

Death 4 (0.2%)

1 (0.0%)

Patient Outcomes

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

1,648 (63.8%)

Other 556 (21.5%)

Required Intervention 240 (9.3%)

Hospitalization 69 (2.7%)

R 35 (1.4%)

H 12 (0.5%)

O 8 (0.3%)

L 7 (0.3%)

Death 4 (0.2%)

Life Threatening 3 (0.1%)

C 1 (0.0%)

S 1 (0.0%)

Disability 1 (0.0%)

Yearly Trend

1994: 1

1997: 13

1998: 20

1999: 17

2000: 23

2001: 27

2002: 24

2003: 21

2004: 16

2005: 15

2006: 10

2007: 5

2008: 18

2009: 3

2010: 33

2011: 46

2012: 32

2013: 41

2014: 19

2015: 21

2016: 49

2017: 59

2018: 82

2019: 148

2020: 144

2021: 102

2022: 283

2023: 202

2024: 468

2025: 320

2026: 266

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 350

COLOPLAST A/S 233

C.R. BARD INC. (COVINGTON) -1018233 77

BOSTON SCIENTIFIC - SPENCER 40

Event Locations

1,782 (70.5%)

I 511 (20.2%)

OTHER 131 (5.2%)

HOSPITAL 40 (1.6%)

HOME 24 (0.9%)

NO INFORMATION 21 (0.8%)

NOT APPLICABLE 14 (0.6%)

OUTPATIENT TREATMENT FACILITY 4 (0.2%)

NURSING HOME 1 (0.0%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs COLOPLAST A/S →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Urethral, 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 (2,528 here).

Handpiece 2,523 Real Time Nucleic Acid Amplification System 2,522 Aid, Transfer 2,510 System 2,503

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4 Electrode, Ion Specific, Potassium 4

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

Disclaimer: MAUDE figures for Catheter, Urethral 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 Catheter, Urethral; 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.

Catheter, Urethral

Event-type mix vs corpus