2026 data FDA MAUDE openFDA FDA Class II

Cutaneous Tissue Adhesive With Mesh

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 §878.4011 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Cutaneous Tissue Adhesive With Mesh LIGHT-BOOK · MAUDE

#484 of 1000 · 2,139 reports · 2012–2026

  • BOOK 2,139 reports
  • RANK #484 of 1000
  • DEATH 1 death-typed
  • INJ 1,960 injury-typed
  • MALF 176 malfunction
  • SPAN 2012–2026
  • PEAK 2025: 295
  • PHOTO Pancreatic Stent

Nearest event-volume peer: Pancreatic Stent, Covered, Metallic, Removable (1 report gap)

Cutaneous Tissue Adhesive With Mesh sits #484 of 1000 among tracked device types with 2,139 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 →

Injury-coded reports run above the device-type norm

Cutaneous Tissue Adhesive With Mesh carries 91.6% INJURY-coded reports, 61.3pp 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 91.6% corpus 30.3% · above corpus mean (+61.3 pp)
  • MALF 8.2% corpus 64.8% · below corpus mean (-56.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 63% of coded problems · Lead manufacturer ETHICON INC. accounts for 95% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Cutaneous Tissue Adhesive With Mesh in the event-volume neighbourhood

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

reports

What this shows Cutaneous Tissue Adhesive With Mesh carries 2,139 MAUDE reports, ranked #484 of 1000.

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

Event Types

Injury 1,960 (91.6%)
Malfunction 176 (8.2%)
2 (0.1%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 1,750 (80.1%)
188 (8.6%)
Other 143 (6.5%)
Hospitalization 47 (2.2%)
R 46 (2.1%)
H 4 (0.2%)
Disability 3 (0.1%)
O 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,337
Appropriate Device Problem Term/Code Not Available 353
Patient-Device Incompatibility 78
Reaction 75
Device Markings/Labelling Problem 73
Other (for use when an appropriate device code cannot be identified) 71
Device Contaminated During Manufacture or Shipping 39
Delivered as Unsterile Product 17
Insufficient Device Problem Information 17
Material Separation 12
Compatibility Problem 7
Tear, Rip or Hole in Device Packaging 7
Loss of or Failure to Bond 6
Material Integrity Problem 6
Patient Device Interaction Problem 6
Coagulation in Device or Device Ingredient 4
Contamination /Decontamination Problem 3
Improper or Incorrect Procedure or Method 3
Incorrect, Inadequate or Imprecise Result or Readings 3
Lack of Effect 3

Yearly Trend

12
2012: 25
13
2013: 54
14
2014: 17
15
2015: 94
16
2016: 125
17
2017: 163
18
2018: 206
19
2019: 153
20
2020: 86
21
2021: 186
22
2022: 175
23
2023: 171
24
2024: 256
25
2025: 295
26
2026: 133

Reports in 2025 (295) held close to the prior two-year average of 214.

Related Entities for Cutaneous Tissue Adhesive With Mesh

Event Locations

1,152 (53.9%)
I 894 (41.8%)
OTHER 56 (2.6%)
NO INFORMATION 27 (1.3%)
HOSPITAL 8 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)

Compare ETHICON INC. vs ETHICON, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cutaneous Tissue Adhesive With 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 (2,139 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Cutaneous Tissue Adhesive With 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 Cutaneous Tissue Adhesive With 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.