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2026 data FDA MAUDE openFDA FDA Class III

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

#633 of 1000 · 1,158 reports · 1995–2026

  • BOOK 1,158 reports
  • RANK #633 of 1000
  • DEATH 8 death-typed
  • INJ 751 injury-typed
  • MALF 165 malfunction
  • SPAN 1995–2026
  • PEAK 2006: 178
  • PHOTO Agent

Nearest event-volume peer: Agent, Tooth Bonding, Resin (1 report gap)

Agent, Bulking, Injectable For Gastro-Urology Use sits #633 of 1000 among tracked device types with 1,158 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 →

Malfunction reports sit below the device-type norm

Agent carries 14.2% MALFUNCTION-coded reports, 50.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 64.9% corpus 30.3% · above corpus mean (+34.6 pp)
  • MALF 14.2% corpus 64.8% · below corpus mean (-50.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 83% of manufacturer-tagged reports · Top event location is 49% 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 1,158 MAUDE reports, ranked #633 of 1000.

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

Event Types

Injury 751 (64.9%)
Other 226 (19.5%)
Malfunction 165 (14.2%)
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 714 (58.8%)
246 (20.2%)
Other 113 (9.3%)
Hospitalization 68 (5.6%)
R 40 (3.3%)
O 9 (0.7%)
Death 8 (0.7%)
Disability 5 (0.4%)
H 4 (0.3%)
S 3 (0.2%)
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 383
Break 142
Insufficient Device Problem Information 123
Device remains implanted 104
Implant extrusion 78
Unknown (for use when the device problem is not known) 76
Other (for use when an appropriate device code cannot be identified) 52
Material Erosion 48
Migration or Expulsion of Device 40
Misapplication 29
Device Operates Differently Than Expected 25
Explanted 24
Appropriate Device Problem Term/Code Not Available 19
No Apparent Adverse Event 18
Normal 16
Device, removal of (non-implant) 15
Leak/Splash 13
Patient-Device Incompatibility 12
Foreign material 11
Occlusion Within Device 8

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: 69

Reports rose to 61 in 2025, up from an average of 41 in the two years before - a recent-year increase, not a lifetime pattern.

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

570 (49.2%)
HOSPITAL 287 (24.8%)
AMBULATORY SURGICAL FACILITY 145 (12.5%)
I 100 (8.6%)
OTHER 30 (2.6%)
UNKNOWN 11 (0.9%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Agent: 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 (1,158 here).

Agent, Tooth Bonding, Resin 1,159 Filter, Infusion Line 1,167 Holder, Ureteral Catheter 1,177 Spinal Pedicle Screw 1,178

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.