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2026 data FDA MAUDE openFDA FDA Class III

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.

FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §876.5280 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Device, Incontinence, Mechanical/Hydraulic MID-BOOK · MAUDE

#149 of 1000 · 18,299 reports · 1994–2026

  • BOOK 18,299 reports
  • RANK #149 of 1000
  • DEATH 9 death-typed
  • INJ 17,752 injury-typed
  • MALF 525 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 2,753
  • PHOTO Phakic Toric Intraocu…

Nearest event-volume peer: Phakic Toric Intraocular Lens (66 report gap)

Device, Incontinence, Mechanical/Hydraulic sits #149 of 1000 among tracked device types with 18,299 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 →

Injury-coded reports run above the device-type norm

Device, Incontinence, Mechanical/Hydraulic carries 97.0% INJURY-coded reports, 66.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 97.0% corpus 30.3% · above corpus mean (+66.7 pp)
  • MALF 2.9% corpus 64.8% · below corpus mean (-62.0 pp)

Lead product-problem code Insufficient Device Problem Information is 20% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 86% of manufacturer-tagged reports · Top event location is 49% 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 18,299 MAUDE reports, ranked #149 of 1000.

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

Event Types

Injury 17,752 (97.0%)
Malfunction 525 (2.9%)
Death 9 (0.0%)
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 12,897 (36.6%)
R 12,441 (35.3%)
Required Intervention 4,217 (12.0%)
H 4,053 (11.5%)
O 546 (1.5%)
516 (1.5%)
Other 512 (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 Device Problem Information 3,952
Adverse Event Without Identified Device or Use Problem 3,871
Mechanical Problem 3,218
Fluid/Blood Leak 3,217
Material Puncture/Hole 1,645
Inadequacy of Device Shape and/or Size 1,217
Migration 509
Defective Device 502
Malposition of Device 293
Inflation Problem 195
Decrease in Pressure 171
Explanted 91
Failure to Cycle 82
Air/Gas in Device 75
Nonstandard Device 65
Difficult or Delayed Activation 61
Disconnection 55
Use of Device Problem 54
Deflation Problem 43
Material Erosion 40

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: 1,071

Reports in 2025 (2,099) held close to the prior two-year average of 1,944.

Related Entities for Device, Incontinence, Mechanical/Hydraulic

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 15,440
AMERICAN MEDICAL SYSTEMS, INC. 2,397
AMERICAN MEDICAL SYSTEMS, INC 84
AMERICAN MEDICAL SYSTEMS INC 21

Event Locations

9,019 (49.3%)
I 6,747 (36.9%)
NOT APPLICABLE 1,985 (10.8%)
OTHER 325 (1.8%)
HOSPITAL 127 (0.7%)
INVALID DATA 59 (0.3%)
HOME 15 (0.1%)
NO INFORMATION 9 (0.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Incontinence, Mechanical/Hydraulic: 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 (18,299 here).

Phakic Toric Intraocular Lens 18,233 Motor, Surgical Instrument, Ac-Powered 18,194 Aligner, Sequential 18,498 Immunoassay Method, Troponin Subunit 18,095

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.