2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Agent, Absorbable Hemostatic, Collagen Based LIGHT-BOOK · MAUDE

#476 of 1000 · 2,061 reports · 1996–2026

  • BOOK 2,061 reports
  • RANK #476 of 1000
  • DEATH 92 death-typed
  • INJ 1,639 injury-typed
  • MALF 300 malfunction
  • SPAN 1996–2026
  • PEAK 2023: 271
  • PHOTO Bur

Nearest event-volume peer: Bur, Surgical, General & Plastic Surgery (1 report gap)

Agent, Absorbable Hemostatic, Collagen Based sits #476 of 1000 among tracked device types with 2,061 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 →

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 4.5% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 79.5% corpus 30.4% · above corpus mean (+49.1 pp)
  • MALF 14.6% corpus 64.5% · below corpus mean (-50.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 35% of coded problems · Lead manufacturer ETHICON INC. accounts for 52% of manufacturer-tagged reports · Top event location is 56% 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

reports

What this shows Agent, Absorbable Hemostatic, Collagen Based carries 2,061 MAUDE reports, ranked #476 of 1000.

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

Event Types

Injury 1,639 (79.5%)
Malfunction 300 (14.6%)
Death 92 (4.5%)
16 (0.8%)
Other 14 (0.7%)

Patient Outcomes

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

Required Intervention 638 (22.5%)
Other 615 (21.7%)
R 469 (16.6%)
443 (15.6%)
Hospitalization 230 (8.1%)
O 195 (6.9%)
Death 78 (2.8%)
Life Threatening 44 (1.6%)
H 36 (1.3%)
L 32 (1.1%)
S 27 (1.0%)
D 15 (0.5%)
Disability 11 (0.4%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 522
Off-Label Use 268
Improper or Incorrect Procedure or Method 204
Appropriate Term/Code Not Available 138
Device Contamination with Chemical or Other Material 71
Insufficient Information 70
Lack of Effect 45
Patient-Device Incompatibility 36
Defective Device 26
Use of Device Problem 22
Patient Device Interaction Problem 19
Device Appears to Trigger Rejection 13
Product Quality Problem 12
Device Operates Differently Than Expected 11
Therapeutic or Diagnostic Output Failure 11
Break 10
Fail-Safe Did Not Operate 9
Device Handling Problem 8
Device Markings/Labelling Problem 8
Unexpected Therapeutic Results 7

Yearly Trend

96
1996: 4
97
1997: 16
98
1998: 16
99
1999: 8
00
2000: 14
01
2001: 43
02
2002: 24
03
2003: 16
04
2004: 21
05
2005: 14
06
2006: 13
07
2007: 15
08
2008: 55
09
2009: 63
10
2010: 76
11
2011: 85
12
2012: 51
13
2013: 62
14
2014: 93
15
2015: 94
16
2016: 85
17
2017: 121
18
2018: 109
19
2019: 151
20
2020: 146
21
2021: 96
22
2022: 58
23
2023: 271
24
2024: 134
25
2025: 94
26
2026: 13

Related Entities for Agent, Absorbable Hemostatic, Collagen Based

Event Locations

1,147 (55.7%)
I 719 (34.9%)
HOSPITAL 81 (3.9%)
OTHER 51 (2.5%)
NO INFORMATION 26 (1.3%)
UNKNOWN 14 (0.7%)
INVALID DATA 13 (0.6%)
AMBULATORY SURGICAL FACILITY 5 (0.2%)
HOME 3 (0.1%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON INC. vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Agent, Absorbable Hemostatic, Collagen Based, 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 (2,061 here).

Similar death-typed counts

Nearest other device types by death-typed report count (92 here), distinct from the volume row.

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.