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2019 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

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).

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FDA MAUDE casebook

openFDA event book Mesh LIGHT-BOOK · MAUDE

#739 of 1000 · 787 reports · 2013–2019

  • BOOK 787 reports
  • RANK #739 of 1000
  • DEATH 1 death-typed
  • INJ 782 injury-typed
  • MALF 4 malfunction
  • SPAN 2013–2019
  • PEAK 2015: 286
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Low Electric Field, Tumor Treatment (3 report gap)

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed sits #739 of 1000 among tracked device types with 787 MAUDE reports spanning 2013–2019. 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 99.4% INJURY-coded reports, 69.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 99.4% corpus 30.3% · above corpus mean (+69.1 pp)
  • MALF 0.5% corpus 64.8% · below corpus mean (-64.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 86% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - MARLBOROUGH accounts for 100% of manufacturer-tagged reports · Top event location I is 62% 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 Apical Vaginal And Uterine Prolapse, Transabdominally Placed carries 787 MAUDE reports, ranked #739 of 1000.

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

Event Types

Injury 782 (99.4%)
Malfunction 4 (0.5%)
Death 1 (0.1%)

Patient Outcomes

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

Other 595 (75.2%)
Disability 97 (12.3%)
Required Intervention 81 (10.2%)
7 (0.9%)
Hospitalization 6 (0.8%)
R 2 (0.3%)
O 1 (0.1%)
S 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 676
Insufficient Device Problem Information 95
Device Operates Differently Than Expected 5
Patient-Device Incompatibility 4
Device Packaging Compromised 2
Component Missing 1
Extrusion 1
Folded 1
Positioning Problem 1
Torn Material 1

Yearly Trend

13
2013: 61
14
2014: 66
15
2015: 286
16
2016: 267
17
2017: 96
18
2018: 9
19
2019: 2

Reports fell to 9 in 2018, down from an average of 182 in the two years before.

Related Entities for Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Top Manufacturers

BOSTON SCIENTIFIC - MARLBOROUGH 681
BOSTON SCIENTIFIC 1
BOSTON SCIENTIFIC CORPORATION 1

Event Locations

I 488 (62.0%)
295 (37.5%)
HOSPITAL 2 (0.3%)
NO INFORMATION 2 (0.3%)

Compare BOSTON SCIENTIFIC - MARLBOROUGH vs BOSTON SCIENTIFIC →

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 (787 here).

Stimulator 790 Support, Patient Position 782 Gown, Surgical 780 Appliance 779

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

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.