2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#365 of 1000 · 3,514 reports · 1999–2026

  • BOOK 3,514 reports
  • RANK #365 of 1000
  • DEATH 7 death-typed
  • INJ 1,901 injury-typed
  • MALF 1,214 malfunction
  • SPAN 1999–2026
  • PEAK 2019: 427
  • PHOTO System

Nearest event-volume peer: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (4 report gap)

Tissue Adhesive For The Topical Approximation Of Skin sits #365 of 1000 among tracked device types with 3,514 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 54.1% corpus 30.4% · above corpus mean (+23.7 pp)
  • MALF 34.5% corpus 64.5% · below corpus mean (-30.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer ETHICON INC. accounts for 87% of manufacturer-tagged reports · Top event location is 47% 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 3,514 MAUDE reports, ranked #365 of 1000.

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

Event Types

Injury 1,901 (54.1%)
Malfunction 1,214 (34.5%)
Other 370 (10.5%)
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 1,509 (42.0%)
1,162 (32.4%)
Other 786 (21.9%)
R 53 (1.5%)
Hospitalization 42 (1.2%)
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 865
Break 252
Fluid/Blood Leak 198
Appropriate Term/Code Not Available 161
Patient Device Interaction Problem 140
Patient-Device Incompatibility 138
Mechanical Problem 96
Material Integrity Problem 88
Device Contaminated During Manufacture or Shipping 72
Gel Leak 64
Crack 57
Insufficient Information 44
Partial Blockage 38
Packaging Problem 24
Leak/Splash 23
Product Quality Problem 16
Material Twisted/Bent 14
Failure To Adhere Or Bond 12
Delivered as Unsterile Product 11
Use of Device Problem 10

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: 22

Related Entities for Tissue Adhesive For The Topical Approximation Of Skin

Top Manufacturers

Event Locations

1,656 (47.1%)
I 1,447 (41.2%)
OTHER 226 (6.4%)
HOSPITAL 134 (3.8%)
NO INFORMATION 38 (1.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Tissue Adhesive For The Topical Approximati…, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,514 here).

Similar death-typed counts

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

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.