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2026 data FDA MAUDE openFDA

Device, Incontinence, Mechanical/Hydraulic

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 Device, Incontinence, Mechanical/Hydraulic MID-BOOK · MAUDE

#148 of 1000 · 17,504 reports · 1994–2026

  • BOOK 17,504 reports
  • RANK #148 of 1000
  • DEATH 9 death-typed
  • INJ 16,966 injury-typed
  • MALF 516 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 2,753
  • PHOTO Leadless Pacemaker

Nearest event-volume peer: Leadless Pacemaker (5 report gap)

Device, Incontinence, Mechanical/Hydraulic sits #148 of 1000 among tracked device types with 17,504 MAUDE reports spanning 1994–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 96.9% corpus 30.4% · above corpus mean (+66.5 pp)
  • MALF 2.9% corpus 64.5% · below corpus mean (-61.6 pp)

Lead product-problem code Insufficient Information is 21% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 85% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

Device, Incontinence, Mechanical/Hydraulic in the event-volume neighbourhood

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

reports

What this shows Device, Incontinence, Mechanical/Hydraulic carries 17,504 MAUDE reports, ranked #148 of 1000.

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

Event Types

Injury 16,966 (96.9%)
Malfunction 516 (2.9%)
Death 9 (0.1%)
Other 8 (0.0%)
5 (0.0%)

Patient Outcomes

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

Hospitalization 12,411 (37.2%)
R 11,955 (35.8%)
Required Intervention 3,772 (11.3%)
H 3,618 (10.8%)
O 541 (1.6%)
506 (1.5%)
Other 485 (1.5%)
Disability 58 (0.2%)
S 15 (0.0%)
Death 9 (0.0%)
L 5 (0.0%)
Congenital Anomaly 2 (0.0%)
Life Threatening 2 (0.0%)

Top Product Problems

Insufficient Information 3,873
Adverse Event Without Identified Device or Use Problem 3,574
Fluid/Blood Leak 3,027
Mechanical Problem 3,002
Material Puncture/Hole 1,552
Inadequacy of Device Shape and/or Size 1,134
Defective Device 500
Migration 468
Malposition of Device 280
Inflation Problem 184
Decrease in Pressure 155
Failure to Cycle 79
Air/Gas in Device 63
Difficult or Delayed Activation 57
Use of Device Problem 49
Disconnection 48
Deflation Problem 42
Nonstandard Device 31
Material Deformation 29
Appropriate Term/Code Not Available 21

Yearly Trend

94
1994: 8
95
1995: 6
96
1996: 676
97
1997: 1,672
98
1998: 16
99
1999: 13
00
2000: 16
01
2001: 5
02
2002: 12
03
2003: 21
04
2004: 8
05
2005: 7
06
2006: 6
07
2007: 7
08
2008: 2
09
2009: 14
10
2010: 25
11
2011: 26
12
2012: 23
13
2013: 22
14
2014: 9
15
2015: 13
16
2016: 6
17
2017: 9
18
2018: 873
19
2019: 2,753
20
2020: 1,743
21
2021: 1,697
22
2022: 1,553
23
2023: 1,778
24
2024: 2,110
25
2025: 2,099
26
2026: 276

Related Entities for Device, Incontinence, Mechanical/Hydraulic

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 14,664
AMERICAN MEDICAL SYSTEMS, INC. 2,397
AMERICAN MEDICAL SYSTEMS, INC 84
AMERICAN MEDICAL SYSTEMS INC 21

Event Locations

8,219 (47.0%)
I 6,752 (38.6%)
NOT APPLICABLE 1,985 (11.3%)
OTHER 325 (1.9%)
HOSPITAL 127 (0.7%)
INVALID DATA 59 (0.3%)
HOME 15 (0.1%)
NO INFORMATION 9 (0.1%)
AMBULATORY SURGICAL FACILITY 6 (0.0%)
UNKNOWN 5 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs AMERICAN MEDICAL SYSTEMS, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Incontinence, Mechanical/Hydraulic, 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 (17,504 here).

Leadless Pacemaker 17,499 Phakic Toric Intraocular Lens 17,499 General Surgery Tray 17,567 Implant, Intragastric For Morbid Obesity 17,588

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Device, Incontinence, Mechanical/Hydraulic 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 Device, Incontinence, Mechanical/Hydraulic; 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.