2026 data FDA MAUDE openFDA FDA Class II

Mesh, Surgical, Polymeric

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, Polymeric HEAVY-BOOK · MAUDE

#21 of 1000 · 170,120 reports · 1992–2026

  • BOOK 170,120 reports
  • RANK #21 of 1000
  • DEATH 852 death-typed
  • INJ 164,116 injury-typed
  • MALF 4,302 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 26,519
  • PHOTO Staple, Implantable

Nearest event-volume peer: Staple, Implantable (508 report gap)

Mesh, Surgical, Polymeric sits #21 of 1000 among tracked device types with 170,120 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 →

Injury-coded reports run above the device-type norm

Mesh, Surgical, Polymeric carries 96.5% INJURY-coded reports, 66.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 96.5% corpus 30.3% · above corpus mean (+66.2 pp)
  • MALF 2.5% corpus 64.8% · below corpus mean (-62.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer DAVOL INC., SUB. C.R. BARD, INC. accounts for 38% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Mesh, Surgical, Polymeric in the event-volume neighbourhood

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

reports

What this shows Mesh, Surgical, Polymeric carries 170,120 MAUDE reports, ranked #21 of 1000.

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

Event Types

Injury 164,116 (96.5%)
Malfunction 4,302 (2.5%)
Death 852 (0.5%)
Other 571 (0.3%)
278 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Required Intervention 99,033 (47.9%)
Disability 27,618 (13.3%)
Other 27,188 (13.1%)
R 19,051 (9.2%)
S 11,979 (5.8%)
Hospitalization 8,868 (4.3%)
5,658 (2.7%)
O 3,292 (1.6%)
H 1,543 (0.7%)
L 1,053 (0.5%)
Life Threatening 736 (0.4%)
Death 659 (0.3%)
D 215 (0.1%)
Congenital Anomaly 25 (0.0%)
C 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 62,155
Defective Device 58,405
Insufficient Device Problem Information 44,811
Patient Device Interaction Problem 32,207
Patient-Device Incompatibility 11,601
Material Erosion 9,258
Migration or Expulsion of Device 6,824
Mechanics Altered 5,409
Appropriate Device Problem Term/Code Not Available 4,213
Material Deformation 3,725
Other (for use when an appropriate device code cannot be identified) 3,701
Explanted 2,681
Migration 2,637
Device Operates Differently Than Expected 2,046
Device remains implanted 1,423
Unknown (for use when the device problem is not known) 1,403
Extrusion 1,341
Material Split, Cut or Torn 1,157
Material Integrity Problem 1,020
Break 739

Yearly Trend

92
1992: 1
94
1994: 2
96
1996: 14
97
1997: 113
98
1998: 252
99
1999: 378
00
2000: 255
01
2001: 335
02
2002: 530
03
2003: 326
04
2004: 443
05
2005: 585
06
2006: 768
07
2007: 1,737
08
2008: 1,569
09
2009: 1,906
10
2010: 2,175
11
2011: 3,608
12
2012: 14,700
13
2013: 26,519
14
2014: 2,683
15
2015: 2,522
16
2016: 2,411
17
2017: 3,945
18
2018: 11,892
19
2019: 21,724
20
2020: 18,815
21
2021: 16,284
22
2022: 11,439
23
2023: 8,025
24
2024: 8,582
25
2025: 3,575
26
2026: 2,007

Reports fell to 3,575 in 2025, down from an average of 8,304 in the two years before.

Related Entities for Mesh, Surgical, Polymeric

Event Locations

93,940 (55.2%)
I 52,249 (30.7%)
HOSPITAL 14,381 (8.5%)
OTHER 7,406 (4.4%)
NO INFORMATION 1,090 (0.6%)
UNKNOWN 579 (0.3%)
NOT APPLICABLE 178 (0.1%)
HOME 142 (0.1%)
AMBULATORY SURGICAL FACILITY 60 (0.0%)
INVALID DATA 39 (0.0%)
OUTPATIENT TREATMENT FACILITY 37 (0.0%)
OPERATING ROOM 8 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 7 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
HOSPICE 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare DAVOL INC., SUB. C.R. BARD, INC. vs ETHICON INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mesh, Surgical, Polymeric: 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 (170,120 here).

Similar death-typed counts

Nearest other device types by death-typed report count (852 here), distinct from the volume row.

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