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2026 data FDA MAUDE openFDA FDA Class II

Tissue Adhesive For The Topical Approximation Of Skin

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 §878.4010 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Tissue Adhesive For The Topical Approximati… LIGHT-BOOK · MAUDE

#369 of 1000 · 3,631 reports · 1999–2026

  • BOOK 3,631 reports
  • RANK #369 of 1000
  • DEATH 7 death-typed
  • INJ 1,990 injury-typed
  • MALF 1,242 malfunction
  • SPAN 1999–2026
  • PEAK 2019: 427
  • PHOTO Sensor

Nearest event-volume peer: Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System (22 report gap)

Tissue Adhesive For The Topical Approximation Of Skin sits #369 of 1000 among tracked device types with 3,631 MAUDE reports spanning 1999–2026. 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

Tissue Adhesive For The Topical Approximati… carries 34.2% MALFUNCTION-coded reports, 30.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 54.8% corpus 30.3% · above corpus mean (+24.5 pp)
  • MALF 34.2% corpus 64.8% · below corpus mean (-30.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer ETHICON INC. accounts for 84% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Tissue Adhesive For The Topical Approximati… in the event-volume neighbourhood

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

reports

What this shows Tissue Adhesive For The Topical Approximation Of Skin carries 3,631 MAUDE reports, ranked #369 of 1000.

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

Event Types

Injury 1,990 (54.8%)
Malfunction 1,242 (34.2%)
Other 370 (10.2%)
22 (0.6%)
Death 7 (0.2%)

Patient Outcomes

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

Required Intervention 1,584 (42.8%)
1,186 (32.1%)
Other 797 (21.5%)
R 53 (1.4%)
Hospitalization 42 (1.1%)
O 13 (0.4%)
Death 7 (0.2%)
S 5 (0.1%)
Disability 4 (0.1%)
Life Threatening 3 (0.1%)
H 2 (0.1%)
L 2 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 951
Reaction 343
Other (for use when an appropriate device code cannot be identified) 328
Break 269
Appropriate Device Problem Term/Code Not Available 207
Fluid/Blood Leak 204
Unknown (for use when the device problem is not known) 172
Patient Device Interaction Problem 160
Patient-Device Incompatibility 145
Misapplication 112
Mechanical Problem 96
Insufficient Device Problem Information 91
Material Integrity Problem 90
Device Contaminated During Manufacture or Shipping 82
Gel Leak 64
Use of Device Problem 62
Crack 60
Partial Blockage 38
Device Operates Differently Than Expected 37
Migration or Expulsion of Device 34

Yearly Trend

99
1999: 73
00
2000: 53
01
2001: 37
02
2002: 54
03
2003: 36
04
2004: 22
05
2005: 35
06
2006: 50
07
2007: 56
08
2008: 32
09
2009: 22
10
2010: 21
11
2011: 93
12
2012: 135
13
2013: 177
14
2014: 199
15
2015: 179
16
2016: 194
17
2017: 182
18
2018: 272
19
2019: 427
20
2020: 225
21
2021: 141
22
2022: 165
23
2023: 130
24
2024: 236
25
2025: 246
26
2026: 139

Reports in 2025 (246) held close to the prior two-year average of 183.

Related Entities for Tissue Adhesive For The Topical Approximation Of Skin

Top Manufacturers

ETHICON INC. 1,775
ETHICON, INC. 259
B BRAUN SURGICAL SA 79

Event Locations

1,769 (48.7%)
I 1,447 (39.9%)
OTHER 226 (6.2%)
HOSPITAL 138 (3.8%)
NO INFORMATION 38 (1.0%)
UNKNOWN 6 (0.2%)
EMERGENCY ROOM 3 (0.1%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON INC. vs ETHICON, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tissue Adhesive For The Topical Approximati…: 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 (3,631 here).

Sensor 3,653 Syringe, Balloon Inflation 3,683 Artificial Heart 3,692 System, Test, Human Chorionic Gonadotropin 3,570

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

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

Disclaimer: MAUDE figures for Tissue Adhesive For The Topical Approximati… 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 Tissue Adhesive For The Topical Approximati…; 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.