Agent, Absorbable Hemostatic, 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, Absorbable Hemostatic, Collagen Based LIGHT-BOOK · MAUDE
#488 of 1000 · 2,108 reports · 1996–2026
- BOOK 2,108 reports
- RANK #488 of 1000
- DEATH 92 death-typed
- INJ 1,676 injury-typed
- MALF 310 malfunction
- SPAN 1996–2026
- PEAK 2023: 271
- PHOTO Bur
Nearest event-volume peer: Bur, Surgical, General & Plastic Surgery (2 report gap)
Agent, Absorbable Hemostatic, Collagen Based sits #488 of 1000 among tracked device types with 2,108 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 →
Malfunction reports sit below the device-type norm
Agent, Absorbable Hemostatic, Collagen Based carries 14.7% MALFUNCTION-coded reports, 50.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
- INJ 79.5% corpus 30.3% · above corpus mean (+49.2 pp)
- MALF 14.7% corpus 64.8% · below corpus mean (-50.1 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer ETHICON INC. accounts for 53% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .
Agent, Absorbable Hemostatic, Collagen Based in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pancreatic St…
Pancreatic Stent, Covered, Metallic, Removable
2,138 reports
- Collector
Collector, Urine, (And Accessories) For Indwelling Catheter
2,118 reports
- Bur
Bur, Surgical, General & Plastic Surgery
2,110 reports
- Agent (this)
Agent, Absorbable Hemostatic, Collagen Based
2,108 reports
- Hydrogel Spac…
Hydrogel Spacer
2,087 reports
- Catheter
Catheter, Percutaneous, Cutting/Scoring
2,083 reports
What this shows Agent, Absorbable Hemostatic, Collagen Based carries 2,108 MAUDE reports, ranked #488 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 fell to 94 in 2025, down from an average of 203 in the two years before.
Related Entities for Agent, Absorbable Hemostatic, Collagen Based
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Agent, Absorbable Hemostatic, Collagen Based: 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 (2,108 here).
Similar death-typed counts
Nearest other device types by death-typed report count (92 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Agent, Absorbable Hemostatic, Collagen Based 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, Absorbable Hemostatic, Collagen Based; 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.