Agent, Absorbable Hemostatic, Non-Collagen Based
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 III (highest risk, premarket approval required), regulated under 21 CFR §878.4490 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Agent LIGHT-BOOK · MAUDE
#531 of 1000 · 1,755 reports · 1996–2026
- BOOK 1,755 reports
- RANK #531 of 1000
- DEATH 27 death-typed
- INJ 1,316 injury-typed
- MALF 402 malfunction
- SPAN 1996–2026
- PEAK 2024: 233
- PHOTO Urethroscope
Nearest event-volume peer: Urethroscope (7 report gap)
Agent, Absorbable Hemostatic, Non-Collagen Based sits #531 of 1000 among tracked device types with 1,755 MAUDE reports spanning 1996–2026. 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
Agent carries 75.0% INJURY-coded reports, 44.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
- INJ 75.0% corpus 30.3% · above corpus mean (+44.7 pp)
- MALF 22.9% corpus 64.8% · below corpus mean (-41.9 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 60% of coded problems · Lead manufacturer ETHICON INC. accounts for 82% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Agent in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Ablation, Microwave And Accessories
1,784 reports
- Cannula
Cannula, Manipulator/Injector, Uterine
1,772 reports
- Cannula
Cannula, Nasal, Oxygen
1,767 reports
- Urethroscope
Urethroscope
1,762 reports
- Agent (this)
Agent, Absorbable Hemostatic, Non-Collagen Based
1,755 reports
- Apparatus
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
1,734 reports
What this shows Agent, Absorbable Hemostatic, Non-Collagen Based carries 1,755 MAUDE reports, ranked #531 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 (230) held close to the prior two-year average of 223.
Related Entities for Agent, Absorbable Hemostatic, Non-Collagen Based
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Agent: 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 (1,755 here).
Similar death-typed counts
Nearest other device types by death-typed report count (27 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Agent 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 Agent; 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.