Fibrin Sealant Preparation Device
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 §880.5860 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Fibrin Sealant Preparation Device LIGHT-BOOK · MAUDE
#951 of 1000 · 419 reports · 2007–2026
- BOOK 419 reports
- RANK #951 of 1000
- DEATH 3 death-typed
- INJ 1 injury-typed
- MALF 413 malfunction
- SPAN 2007–2026
- PEAK 2022: 103
- PHOTO Table, Radiologic
Nearest event-volume peer: Table, Radiologic (1 report gap)
Fibrin Sealant Preparation Device sits #951 of 1000 among tracked device types with 419 MAUDE reports spanning 2007–2026. 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 run above the device-type norm
Fibrin Sealant Preparation Device carries 98.6% MALFUNCTION-coded reports, 33.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
- INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
- MALF 98.6% corpus 64.8% · above corpus mean (+33.7 pp)
Lead product-problem code Failure to Disconnect is 49% of coded problems · Lead manufacturer ETHICON INC. accounts for 98% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .
Fibrin Sealant Preparation Device in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Cuff
Cuff, Tracheal Tube, Inflatable
421 reports
- Fibrin Sealan… (this)
Fibrin Sealant Preparation Device
419 reports
- Table
Table, Radiologic
418 reports
- System
System, Gastrointestinal Motility (Electrical)
417 reports
- Stimulator
Stimulator, Carotid Sinus Nerve
416 reports
- Burr
Burr, Orthopedic
414 reports
What this shows Fibrin Sealant Preparation Device carries 419 MAUDE reports, ranked #951 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (81) held close to the prior two-year average of 65.
Related Entities for Fibrin Sealant Preparation Device
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Fibrin Sealant Preparation Device: 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 (419 here).
Similar death-typed counts
Nearest other device types by death-typed report count (3 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Fibrin Sealant Preparation Device 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 Fibrin Sealant Preparation Device; 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.