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2026 data FDA MAUDE openFDA

Agent, Bulking, Injectable For Gastro-Urology Use

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.

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FDA MAUDE casebook

openFDA event book Agent LIGHT-BOOK · MAUDE

#628 of 1000 · 1,104 reports · 1995–2026

  • BOOK 1,104 reports
  • RANK #628 of 1000
  • DEATH 8 death-typed
  • INJ 740 injury-typed
  • MALF 122 malfunction
  • SPAN 1995–2026
  • PEAK 2006: 178
  • PHOTO Intervertebral Fusion…

Nearest event-volume peer: Intervertebral Fusion Device With Bone Graft, Cervical (1 report gap)

Agent, Bulking, Injectable For Gastro-Urology Use sits #628 of 1000 among tracked device types with 1,104 MAUDE reports spanning 1995–2026. 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 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 67.0% corpus 30.4% · above corpus mean (+36.6 pp)
  • MALF 11.1% corpus 64.5% · below corpus mean (-53.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 63% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 83% of manufacturer-tagged reports · Top event location is 47% 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, Bulking, Injectable For Gastro-Urology Use carries 1,104 MAUDE reports, ranked #628 of 1000.

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

Event Types

Injury 740 (67.0%)
Other 226 (20.5%)
Malfunction 122 (11.1%)
8 (0.7%)
Death 8 (0.7%)

Patient Outcomes

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

Required Intervention 712 (61.3%)
197 (17.0%)
Other 113 (9.7%)
Hospitalization 68 (5.9%)
R 39 (3.4%)
O 9 (0.8%)
Death 8 (0.7%)
H 4 (0.3%)
Disability 4 (0.3%)
S 3 (0.3%)
L 2 (0.2%)
Life Threatening 2 (0.2%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 243
Break 81
Insufficient Information 11
Migration or Expulsion of Device 9
Patient-Device Incompatibility 7
Material Erosion 6
Unexpected Therapeutic Results 6
Improper or Incorrect Procedure or Method 4
Appropriate Term/Code Not Available 3
Difficult to Remove 3
Malposition of Device 3
Calcified 2
Defective Device 2
Patient Device Interaction Problem 2
Bent 1
Contamination /Decontamination Problem 1
Device Contamination with Chemical or Other Material 1
Device Operational Issue 1
Device Sensing Problem 1
Difficult to Advance 1

Yearly Trend

95
1995: 1
00
2000: 2
01
2001: 1
03
2003: 4
04
2004: 24
05
2005: 78
06
2006: 178
07
2007: 45
08
2008: 25
09
2009: 25
10
2010: 38
11
2011: 55
12
2012: 60
13
2013: 62
14
2014: 52
15
2015: 59
16
2016: 72
17
2017: 86
18
2018: 36
19
2019: 8
20
2020: 7
21
2021: 11
22
2022: 18
23
2023: 16
24
2024: 65
25
2025: 61
26
2026: 15

Related Entities for Agent, Bulking, Injectable For Gastro-Urology Use

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 160
C.R. BARD, INC. (COVINGTON) 33

Event Locations

516 (46.7%)
HOSPITAL 287 (26.0%)
AMBULATORY SURGICAL FACILITY 145 (13.1%)
I 100 (9.1%)
OTHER 30 (2.7%)
UNKNOWN 11 (1.0%)
HOME 7 (0.6%)
NO INFORMATION 3 (0.3%)
AMBULATORY SURGICAL CENTER 2 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs C.R. BARD, INC. (COVINGTON) →

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 (1,104 here).

Intervertebral Fusion Device With Bone Graft 1,103 Pulmonic Valved Conduit 1,107 Epidural Anesthesia Kit 1,100 Dilator, Catheter, Ureteral 1,095

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8 Container 8

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.