2026 data FDA MAUDE openFDA FDA Class III

Sealant, Dural

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 Sealant, Dural LIGHT-BOOK · MAUDE

#847 of 1000 · 576 reports · 2005–2026

  • BOOK 576 reports
  • RANK #847 of 1000
  • DEATH 2 death-typed
  • INJ 317 injury-typed
  • MALF 254 malfunction
  • SPAN 2005–2026
  • PEAK 2025: 59
  • PHOTO Injector

Nearest event-volume peer: Injector, Contrast Medium, Automatic (0 report gap)

Sealant, Dural sits #847 of 1000 among tracked device types with 576 MAUDE reports spanning 2005–2026. 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

Sealant, Dural carries 55.0% INJURY-coded reports, 24.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 55.0% corpus 30.3% · above corpus mean (+24.7 pp)
  • MALF 44.1% corpus 64.8% · below corpus mean (-20.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 17% of coded problems · Lead manufacturer COVIDIEN accounts for 100% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Sealant, Dural in the event-volume neighbourhood

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

reports

What this shows Sealant, Dural carries 576 MAUDE reports, ranked #847 of 1000.

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

Event Types

Injury 317 (55.0%)
Malfunction 254 (44.1%)
3 (0.5%)
Death 2 (0.3%)

Patient Outcomes

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

319 (49.6%)
Other 136 (21.2%)
Required Intervention 76 (11.8%)
R 46 (7.2%)
Hospitalization 40 (6.2%)
O 11 (1.7%)
S 5 (0.8%)
L 4 (0.6%)
H 2 (0.3%)
Death 2 (0.3%)
Life Threatening 2 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 90
Insufficient Device Problem Information 71
Device Operates Differently Than Expected 65
Unknown (for use when the device problem is not known) 44
Improper Chemical Reaction 43
Appropriate Device Problem Term/Code Not Available 40
Leak/Splash 33
Fluid/Blood Leak 32
Chemical Problem 23
Coagulation in Device or Device Ingredient 10
Failure To Adhere Or Bond 10
Material Integrity Problem 10
Implant, removal of 9
Device Ingredient or Reagent Problem 8
Output Problem 8
Use of Device Problem 8
Manufacturing, Packaging or Shipping Problem 7
Device remains implanted 6
Explanted 6
Patient-Device Incompatibility 6

Yearly Trend

05
2005: 1
06
2006: 5
07
2007: 52
08
2008: 23
09
2009: 6
10
2010: 11
11
2011: 33
12
2012: 33
13
2013: 36
14
2014: 26
15
2015: 21
16
2016: 23
17
2017: 29
18
2018: 45
19
2019: 37
20
2020: 24
21
2021: 20
22
2022: 39
23
2023: 19
24
2024: 20
25
2025: 59
26
2026: 14

Reports rose to 59 in 2025, up from an average of 20 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Sealant, Dural

Top Manufacturers

Event Locations

383 (66.5%)
I 174 (30.2%)
HOSPITAL 12 (2.1%)
NO INFORMATION 7 (1.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sealant, Dural: 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 (576 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Sealant, Dural 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 Sealant, Dural; 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.