2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Agent LIGHT-BOOK · MAUDE

#532 of 1000 · 1,629 reports · 1996–2026

  • BOOK 1,629 reports
  • RANK #532 of 1000
  • DEATH 25 death-typed
  • INJ 1,207 injury-typed
  • MALF 387 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 233
  • PHOTO Cement, Dental

Nearest event-volume peer: Cement, Dental (4 report gap)

Agent, Absorbable Hemostatic, Non-Collagen Based sits #532 of 1000 among tracked device types with 1,629 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 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
  • INJ 74.1% corpus 30.4% · above corpus mean (+43.7 pp)
  • MALF 23.8% corpus 64.5% · below corpus mean (-40.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 63% of coded problems · Lead manufacturer ETHICON INC. accounts for 81% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Agent in the event-volume neighbourhood

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

reports

What this shows Agent, Absorbable Hemostatic, Non-Collagen Based carries 1,629 MAUDE reports, ranked #532 of 1000.

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

Event Types

Injury 1,207 (74.1%)
Malfunction 387 (23.8%)
Death 25 (1.5%)
Other 9 (0.6%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 1,006 (59.4%)
383 (22.6%)
Other 151 (8.9%)
R 51 (3.0%)
Hospitalization 39 (2.3%)
Death 24 (1.4%)
Life Threatening 9 (0.5%)
O 8 (0.5%)
L 7 (0.4%)
Disability 6 (0.4%)
S 5 (0.3%)
H 3 (0.2%)
D 2 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 917
Device Markings/Labelling Problem 99
Delivered as Unsterile Product 86
Patient-Device Incompatibility 65
Device Contaminated During Manufacture or Shipping 59
Appropriate Term/Code Not Available 54
Material Integrity Problem 29
Patient Device Interaction Problem 28
Insufficient Information 24
Break 17
Use of Device Problem 14
Degraded 13
Packaging Problem 11
Component Missing 10
Product Quality Problem 9
Detachment of Device or Device Component 6
Device Contamination with Chemical or Other Material 6
Torn Material 6
Incorrect, Inadequate or Imprecise Result or Readings 5
Loss of or Failure to Bond 5

Yearly Trend

96
1996: 1
97
1997: 3
98
1998: 1
99
1999: 1
00
2000: 5
01
2001: 4
02
2002: 6
03
2003: 5
04
2004: 8
05
2005: 8
06
2006: 14
07
2007: 2
08
2008: 4
11
2011: 10
12
2012: 30
13
2013: 60
14
2014: 6
15
2015: 2
16
2016: 2
17
2017: 30
18
2018: 84
19
2019: 120
20
2020: 173
21
2021: 209
22
2022: 144
23
2023: 212
24
2024: 233
25
2025: 230
26
2026: 22

Related Entities for Agent, Absorbable Hemostatic, Non-Collagen Based

Event Locations

904 (55.5%)
I 567 (34.8%)
OTHER 75 (4.6%)
HOSPITAL 56 (3.4%)
UNKNOWN 12 (0.7%)
NO INFORMATION 8 (0.5%)
HOME 4 (0.2%)
OPERATING ROOM 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare ETHICON INC. vs ETHICON, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Agent, 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 (1,629 here).

Similar death-typed counts

Nearest other device types by death-typed report count (25 here), distinct from the volume row.

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.