2025 data FDA MAUDE openFDA

Agents, Embolic, For Treatment Of Uterine Fibroids

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 Agents LIGHT-BOOK · MAUDE

#894 of 1000 · 471 reports · 2001–2025

  • BOOK 471 reports
  • RANK #894 of 1000
  • DEATH 18 death-typed
  • INJ 239 injury-typed
  • MALF 28 malfunction
  • SPAN 2001–2025
  • PEAK 2005: 61
  • PHOTO System

Nearest event-volume peer: System, Identification, Hepatitis B Antigen (1 report gap)

Agents, Embolic, For Treatment Of Uterine Fibroids sits #894 of 1000 among tracked device types with 471 MAUDE reports spanning 2001–2025. 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 3.8% corpus 1.5% · above corpus mean (+2.3 pp)
  • INJ 50.7% corpus 30.4% · above corpus mean (+20.3 pp)
  • MALF 5.9% corpus 64.5% · below corpus mean (-58.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 75% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - CORK accounts for 56% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Agents in the event-volume neighbourhood

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

reports

What this shows Agents, Embolic, For Treatment Of Uterine Fibroids carries 471 MAUDE reports, ranked #894 of 1000.

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

Event Types

Injury 239 (50.7%)
Other 184 (39.1%)
Malfunction 28 (5.9%)
Death 18 (3.8%)
2 (0.4%)

Patient Outcomes

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

Other 281 (49.8%)
Hospitalization 67 (11.9%)
52 (9.2%)
O 39 (6.9%)
Required Intervention 35 (6.2%)
R 25 (4.4%)
Death 18 (3.2%)
S 14 (2.5%)
L 12 (2.1%)
Disability 11 (2.0%)
Life Threatening 6 (1.1%)
H 3 (0.5%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 53
Therapy Delivered to Incorrect Body Area 7
Failure to Deliver 2
Failure to Infuse 2
Contamination 1
Defective Device 1
Device Packaging Compromised 1
Mechanical Jam 1
Missing Value Reason 1
Unsealed Device Packaging 1
Use of Device Problem 1

Yearly Trend

01
2001: 1
02
2002: 11
03
2003: 60
04
2004: 45
05
2005: 61
06
2006: 44
07
2007: 46
08
2008: 23
09
2009: 11
10
2010: 24
11
2011: 16
12
2012: 21
13
2013: 9
14
2014: 15
15
2015: 16
16
2016: 14
17
2017: 11
18
2018: 7
19
2019: 4
20
2020: 1
21
2021: 4
22
2022: 20
23
2023: 3
24
2024: 1
25
2025: 3

Related Entities for Agents, Embolic, For Treatment Of Uterine Fibroids

Event Locations

206 (43.7%)
UNKNOWN 198 (42.0%)
I 40 (8.5%)
HOME 20 (4.2%)
HOSPITAL 4 (0.8%)
NO INFORMATION 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)

Compare BOSTON SCIENTIFIC - CORK vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Agents, 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 (471 here).

Similar death-typed counts

Nearest other device types by death-typed report count (18 here), distinct from the volume row.

Disclaimer: MAUDE figures for Agents 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 Agents; 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.