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2026 data FDA MAUDE openFDA

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

#91 of 1000 · 37,213 reports · 1993–2026

  • BOOK 37,213 reports
  • RANK #91 of 1000
  • DEATH 10 death-typed
  • INJ 33,739 injury-typed
  • MALF 3,311 malfunction
  • SPAN 1993–2026
  • PEAK 1997: 4,323
  • PHOTO Hexokinase, Glucose

Nearest event-volume peer: Hexokinase, Glucose (310 report gap)

Device, Impotence, Mechanical/Hydraulic sits #91 of 1000 among tracked device types with 37,213 MAUDE reports spanning 1993–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 90.7% corpus 30.4% · above corpus mean (+60.2 pp)
  • MALF 8.9% corpus 64.5% · below corpus mean (-55.6 pp)

Lead product-problem code Fluid/Blood Leak is 15% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 51% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

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

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

reports

What this shows Device, Impotence, Mechanical/Hydraulic carries 37,213 MAUDE reports, ranked #91 of 1000.

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

Event Types

Injury 33,739 (90.7%)
Malfunction 3,311 (8.9%)
Other 112 (0.3%)
41 (0.1%)
Death 10 (0.0%)

Patient Outcomes

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

Hospitalization 19,116 (31.9%)
R 18,395 (30.7%)
Required Intervention 11,389 (19.0%)
H 3,662 (6.1%)
3,271 (5.5%)
Other 3,081 (5.1%)
O 644 (1.1%)
Disability 245 (0.4%)
S 53 (0.1%)
Death 12 (0.0%)
L 9 (0.0%)
Life Threatening 6 (0.0%)
Congenital Anomaly 4 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 5,691
Mechanical Problem 5,320
Inflation Problem 4,869
Adverse Event Without Identified Device or Use Problem 4,539
Material Puncture/Hole 3,270
Insufficient Information 3,016
Fracture 1,778
Migration 1,537
Inadequacy of Device Shape and/or Size 1,247
Defective Device 898
Deflation Problem 883
Break 851
Collapse 821
Malposition of Device 725
Pumping Problem 567
Degraded 500
Leak/Splash 498
Material Deformation 293
Appropriate Term/Code Not Available 233
Failure to Cycle 218

Yearly Trend

93
1993: 11
94
1994: 58
95
1995: 87
96
1996: 1,839
97
1997: 4,323
98
1998: 258
99
1999: 88
00
2000: 311
01
2001: 569
02
2002: 400
03
2003: 582
04
2004: 476
05
2005: 427
06
2006: 259
07
2007: 11
08
2008: 16
09
2009: 15
10
2010: 14
11
2011: 11
12
2012: 11
13
2013: 19
14
2014: 27
15
2015: 9
16
2016: 7
17
2017: 512
18
2018: 1,677
19
2019: 4,010
20
2020: 3,562
21
2021: 3,718
22
2022: 3,203
23
2023: 3,675
24
2024: 4,078
25
2025: 2,577
26
2026: 373

Related Entities for Device, Impotence, Mechanical/Hydraulic

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 16,385
COLOPLAST A/S 10,817
AMERICAN MEDICAL SYSTEMS, INC. 4,744
AMERICAN MEDICAL SYSTEMS, INC 140

Event Locations

17,549 (47.2%)
I 12,626 (33.9%)
NOT APPLICABLE 5,043 (13.6%)
OTHER 901 (2.4%)
HOSPITAL 649 (1.7%)
INVALID DATA 290 (0.8%)
HOME 74 (0.2%)
UNKNOWN 48 (0.1%)
NO INFORMATION 18 (0.0%)
AMBULATORY SURGICAL FACILITY 12 (0.0%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs COLOPLAST A/S →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Impotence, 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 (37,213 here).

Hexokinase, Glucose 37,523 Insulin Pump Secondary Display 37,844 Plate, Fixation, Bone 37,887 Rod 36,507

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Accessories, Catheter 10 Adaptor, Hygiene 10 Cabinet, Table And Tray, Anesthesia 10 Chair, Adjustable, Mechanical 10

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

Disclaimer: MAUDE figures for Device, Impotence, 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, Impotence, 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.