2026 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical

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, Surgical MID-BOOK · MAUDE

#199 of 1000 · 11,595 reports · 1992–2026

  • BOOK 11,595 reports
  • RANK #199 of 1000
  • DEATH 47 death-typed
  • INJ 10,101 injury-typed
  • MALF 605 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 3,351
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (59 report gap)

Mesh, Surgical sits #199 of 1000 among tracked device types with 11,595 MAUDE reports spanning 1992–2026. 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 →

Malfunction reports sit below the device-type norm

Mesh, Surgical carries 5.2% MALFUNCTION-coded reports, 59.6pp below 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 87.1% corpus 30.3% · above corpus mean (+56.8 pp)
  • MALF 5.2% corpus 64.8% · below corpus mean (-59.6 pp)

Lead product-problem code Insufficient Device Problem Information is 37% of coded problems · Lead manufacturer ETHICON INC. accounts for 75% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Mesh, Surgical in the event-volume neighbourhood

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

reports

What this shows Mesh, Surgical carries 11,595 MAUDE reports, ranked #199 of 1000.

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

Event Types

Injury 10,101 (87.1%)
Other 814 (7.0%)
Malfunction 605 (5.2%)
Death 47 (0.4%)
28 (0.2%)

Patient Outcomes

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

Required Intervention 5,044 (40.4%)
Disability 2,974 (23.8%)
Other 1,874 (15.0%)
916 (7.3%)
Hospitalization 697 (5.6%)
R 508 (4.1%)
O 120 (1.0%)
S 116 (0.9%)
H 93 (0.7%)
L 69 (0.6%)
Death 53 (0.4%)
Life Threatening 25 (0.2%)
D 6 (0.0%)

Top Product Problems

Insufficient Device Problem Information 4,222
Adverse Event Without Identified Device or Use Problem 3,765
Appropriate Device Problem Term/Code Not Available 738
Migration or Expulsion of Device 312
Patient-Device Incompatibility 257
Other (for use when an appropriate device code cannot be identified) 219
Patient Device Interaction Problem 213
Device Operates Differently Than Expected 201
Unknown (for use when the device problem is not known) 174
Needle, separation 158
Defective Device 134
Explanted 133
Break 116
Material Disintegration 110
Unexpected Therapeutic Results 104
Torn Material 100
Detachment Of Device Component 94
Material Erosion 87
Migration 68
Degraded 66

Yearly Trend

92
1992: 2
94
1994: 10
95
1995: 5
96
1996: 10
97
1997: 23
98
1998: 23
99
1999: 12
00
2000: 19
01
2001: 19
02
2002: 35
03
2003: 46
04
2004: 32
05
2005: 42
06
2006: 39
07
2007: 60
08
2008: 141
09
2009: 476
10
2010: 197
11
2011: 288
12
2012: 467
13
2013: 3,351
14
2014: 1,093
15
2015: 977
16
2016: 509
17
2017: 529
18
2018: 357
19
2019: 418
20
2020: 457
21
2021: 369
22
2022: 375
23
2023: 485
24
2024: 384
25
2025: 233
26
2026: 112

Reports fell to 233 in 2025, down from an average of 435 in the two years before.

Related Entities for Mesh, Surgical

Top Manufacturers

Event Locations

7,140 (61.6%)
I 2,751 (23.7%)
HOSPITAL 1,378 (11.9%)
NO INFORMATION 202 (1.7%)
OTHER 53 (0.5%)
NOT APPLICABLE 23 (0.2%)
UNKNOWN 23 (0.2%)
INVALID DATA 11 (0.1%)
HOME 8 (0.1%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON INC. vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mesh, Surgical: 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 (11,595 here).

Similar death-typed counts

Nearest other device types by death-typed report count (47 here), distinct from the volume row.

Disclaimer: MAUDE figures for Mesh, Surgical 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, Surgical; 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.