2023 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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

#755 of 1000 · 756 reports · 2008–2023

  • BOOK 756 reports
  • RANK #755 of 1000
  • DEATH 0 death-typed
  • INJ 752 injury-typed
  • MALF 2 malfunction
  • SPAN 2008–2023
  • PEAK 2016: 299
  • PHOTO Punch, Surgical

Nearest event-volume peer: Punch, Surgical (0 report gap)

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator sits #755 of 1000 among tracked device types with 756 MAUDE reports spanning 2008–2023. 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 99.5% INJURY-coded reports, 69.2pp 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 99.5% corpus 30.3% · above corpus mean (+69.2 pp)
  • MALF 0.3% corpus 64.8% · below corpus mean (-64.6 pp)

Lead product-problem code Insufficient Device Problem Information is 65% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 92% of manufacturer-tagged reports · Top event location I is 45% 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, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator carries 756 MAUDE reports, ranked #755 of 1000.

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

Event Types

Injury 752 (99.5%)
2 (0.3%)
Malfunction 2 (0.3%)

Patient Outcomes

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

Disability 612 (79.4%)
Required Intervention 114 (14.8%)
18 (2.3%)
S 10 (1.3%)
Hospitalization 10 (1.3%)
R 3 (0.4%)
O 2 (0.3%)
Other 2 (0.3%)

Top Product Problems

Insufficient Device Problem Information 496
Adverse Event Without Identified Device or Use Problem 205
Device Operates Differently Than Expected 19
Appropriate Device Problem Term/Code Not Available 11
Unexpected Therapeutic Results 6
Patient-Device Incompatibility 4
Break 3
Material Erosion 3
Material Protrusion/Extrusion 3
Extrusion 2
Migration or Expulsion of Device 2
Defective Component 1
Difficult to Remove 1
Fluid/Blood Leak 1
Invalid Sensing 1
Malposition of Device 1
Patient Device Interaction Problem 1
Suture line disruption 1
Therapeutic or Diagnostic Output Failure 1

Yearly Trend

08
2008: 1
13
2013: 84
14
2014: 256
15
2015: 73
16
2016: 299
17
2017: 11
18
2018: 4
19
2019: 17
20
2020: 4
21
2021: 5
22
2022: 1
23
2023: 1

Reports fell to 1 in 2022, down from an average of 5 in the two years before.

Related Entities for Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Top Manufacturers

Event Locations

I 337 (44.6%)
326 (43.1%)
HOSPITAL 89 (11.8%)
NO INFORMATION 4 (0.5%)

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

Nationwide devices with a comparable report-volume footprint

Mesh 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 (756 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 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.