2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Mesh LIGHT-BOOK · MAUDE

#556 of 1000 · 1,501 reports · 2012–2026

  • BOOK 1,501 reports
  • RANK #556 of 1000
  • DEATH 7 death-typed
  • INJ 1,431 injury-typed
  • MALF 61 malfunction
  • SPAN 2012–2026
  • PEAK 2019: 406
  • PHOTO Laser, Ophthalmic

Nearest event-volume peer: Laser, Ophthalmic (9 report gap)

Mesh, Surgical, For Stress Urinary Incontinence, Male sits #556 of 1000 among tracked device types with 1,501 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 →

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 0.5% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 95.3% corpus 30.4% · above corpus mean (+64.9 pp)
  • MALF 4.1% corpus 64.5% · below corpus mean (-60.4 pp)

Lead product-problem code Insufficient Information is 74% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 92% of manufacturer-tagged reports · Top event location I is 67% 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 1,501 MAUDE reports, ranked #556 of 1000.

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

Event Types

Injury 1,431 (95.3%)
Malfunction 61 (4.1%)
Death 7 (0.5%)
Other 2 (0.1%)

Patient Outcomes

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

Hospitalization 1,143 (41.3%)
R 1,070 (38.7%)
Required Intervention 180 (6.5%)
H 135 (4.9%)
Other 87 (3.1%)
67 (2.4%)
O 60 (2.2%)
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 Information 1,003
Adverse Event Without Identified Device or Use Problem 198
Mechanical Problem 44
Defective Device 28
Break 20
Malposition of Device 17
Material Split, Cut or Torn 10
Premature Activation 7
Device Operates Differently Than Expected 4
Torn Material 4
Use of Device Problem 4
Component Missing 3
Device Dislodged or Dislocated 3
Material Frayed 3
Migration 3
Migration or Expulsion of Device 3
Appropriate Term/Code Not Available 2
Connection Problem 2
Detachment of Device or Device Component 2
Device Contaminated During Manufacture or Shipping 2

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: 3

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

Event Locations

I 1,005 (67.0%)
487 (32.4%)
NO INFORMATION 6 (0.4%)
HOSPITAL 2 (0.1%)
OTHER 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs COLOPLAST A/S →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Mesh, 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 (1,501 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 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.