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2025 data FDA MAUDE openFDA FDA Class I

Device, Incontinence, Urosheath Type, Non-Sterile

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).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Device LIGHT-BOOK · MAUDE

#688 of 1000 · 909 reports · 2012–2025

  • BOOK 909 reports
  • RANK #688 of 1000
  • DEATH 0 death-typed
  • INJ 169 injury-typed
  • MALF 740 malfunction
  • SPAN 2012–2025
  • PEAK 2020: 180
  • PHOTO Implant

Nearest event-volume peer: Implant, Fixation Device, Spinal (0 report gap)

Device, Incontinence, Urosheath Type, Non-Sterile sits #688 of 1000 among tracked device types with 909 MAUDE reports spanning 2012–2025. 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 81.4% MALFUNCTION-coded reports, 16.6pp 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 18.6% corpus 30.3% · below corpus mean (-11.7 pp)
  • MALF 81.4% corpus 64.8% · above corpus mean (+16.6 pp)

Lead product-problem code Nonstandard Device is 46% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 97% of manufacturer-tagged reports · Top event location I is 74% 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, Incontinence, Urosheath Type, Non-Sterile carries 909 MAUDE reports, ranked #688 of 1000.

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

Event Types

Malfunction 740 (81.4%)
Injury 169 (18.6%)

Patient Outcomes

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

461 (49.5%)
Other 366 (39.3%)
Required Intervention 73 (7.8%)
R 12 (1.3%)
Hospitalization 9 (1.0%)
O 7 (0.8%)
H 3 (0.3%)

Top Product Problems

Nonstandard Device 526
Difficult to Remove 144
Adverse Event Without Identified Device or Use Problem 64
Physical Resistance/Sticking 50
Material Integrity Problem 47
Biocompatibility 43
Device Operates Differently Than Expected 41
Sticking 33
Patient-Device Incompatibility 32
Product Quality Problem 30
Component Missing 18
Inadequate Instructions for Healthcare Professional 17
Loss of or Failure to Bond 16
Material Deformation 15
Patient Device Interaction Problem 15
Inadequacy of Device Shape and/or Size 14
Device Markings/Labelling Problem 13
Defective Device 12
Inaccurate Flow Rate 11
Insufficient Device Problem Information 11

Yearly Trend

12
2012: 1
14
2014: 1
15
2015: 1
16
2016: 12
17
2017: 109
18
2018: 147
19
2019: 131
20
2020: 180
21
2021: 148
22
2022: 111
23
2023: 44
24
2024: 10
25
2025: 14

Reports fell to 10 in 2024, down from an average of 78 in the two years before.

Related Entities for Device, Incontinence, Urosheath Type, Non-Sterile

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 825
C.R. BARD INC. (COVINGTON) -1018233 15
MEDLINE INDUSTRIES, LP 7
COLOPLAST A/S 4

Event Locations

I 669 (73.6%)
220 (24.2%)
OTHER 15 (1.7%)
HOSPITAL 3 (0.3%)
HOME 1 (0.1%)
NO INFORMATION 1 (0.1%)

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

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 (909 here).

Implant, Fixation Device, Spinal 909 Appliance 910 Passer 906 Enzyme Immunoassay, Diphenylhydantoin 905

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.