2026 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, For Stress Urinary Incontinence, Male

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 §878.3300 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Mesh LIGHT-BOOK · MAUDE

#567 of 1000 · 1,516 reports · 2012–2026

  • BOOK 1,516 reports
  • RANK #567 of 1000
  • DEATH 6 death-typed
  • INJ 1,444 injury-typed
  • MALF 64 malfunction
  • SPAN 2012–2026
  • PEAK 2019: 406
  • PHOTO Continuous Glucose Mo…

Nearest event-volume peer: Continuous Glucose Monitor, Implanted, Adjunctive Use (2 report gap)

Mesh, Surgical, For Stress Urinary Incontinence, Male sits #567 of 1000 among tracked device types with 1,516 MAUDE reports spanning 2012–2026. 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

Mesh carries 95.3% INJURY-coded reports, 65.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 95.3% corpus 30.3% · above corpus mean (+65.0 pp)
  • MALF 4.2% corpus 64.8% · below corpus mean (-60.6 pp)

Lead product-problem code Insufficient Device Problem Information is 69% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 92% of manufacturer-tagged reports · Top event location I is 66% of location-tagged rows .

Mesh in the event-volume neighbourhood

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

reports

What this shows Mesh, Surgical, For Stress Urinary Incontinence, Male carries 1,516 MAUDE reports, ranked #567 of 1000.

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

Event Types

Injury 1,444 (95.3%)
Malfunction 64 (4.2%)
Death 6 (0.4%)
Other 2 (0.1%)

Patient Outcomes

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

Hospitalization 1,150 (41.2%)
R 1,077 (38.6%)
Required Intervention 182 (6.5%)
H 137 (4.9%)
Other 88 (3.2%)
71 (2.5%)
O 60 (2.1%)
Disability 10 (0.4%)
S 8 (0.3%)
Death 6 (0.2%)
L 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Insufficient Device Problem Information 1,052
Adverse Event Without Identified Device or Use Problem 267
Mechanical Problem 46
Defective Device 28
Break 23
Malposition of Device 22
Device Operates Differently Than Expected 14
Material Split, Cut or Torn 10
Migration or Expulsion of Device 8
Premature Activation 7
Material Erosion 6
Device Dislodged or Dislocated 5
Migration 5
Torn Material 5
Detachment of Device or Device Component 4
Improper or Incorrect Procedure or Method 4
Use of Device Problem 4
Component Missing 3
Difficult to Insert 3
Material Frayed 3

Yearly Trend

12
2012: 1
13
2013: 33
14
2014: 72
15
2015: 42
16
2016: 26
17
2017: 16
18
2018: 111
19
2019: 406
20
2020: 261
21
2021: 213
22
2022: 199
23
2023: 28
24
2024: 43
25
2025: 47
26
2026: 18

Reports in 2025 (47) held close to the prior two-year average of 36.

Related Entities for Mesh, Surgical, For Stress Urinary Incontinence, Male

Event Locations

I 1,004 (66.2%)
503 (33.2%)
NO INFORMATION 6 (0.4%)
HOSPITAL 2 (0.1%)
OTHER 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs COLOPLAST A/S →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mesh: 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 (1,516 here).

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Disclaimer: MAUDE figures for Mesh 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 Mesh; 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.