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2026 data FDA MAUDE openFDA

Prosthesis, Penis, Inflatable

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 Prosthesis, Penis, Inflatable LIGHT-BOOK · MAUDE

#456 of 1000 · 2,225 reports · 1994–2026

  • BOOK 2,225 reports
  • RANK #456 of 1000
  • DEATH 1 death-typed
  • INJ 2,056 injury-typed
  • MALF 163 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,637
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intravascular Occluding, Temporary (7 report gap)

Prosthesis, Penis, Inflatable sits #456 of 1000 among tracked device types with 2,225 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 92.4% corpus 30.4% · above corpus mean (+62.0 pp)
  • MALF 7.3% corpus 64.5% · below corpus mean (-57.2 pp)

Lead product-problem code Mechanical Problem is 19% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 97% of manufacturer-tagged reports · Top event location is 96% of location-tagged rows .

Prosthesis, Penis, Inflatable in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Penis, Inflatable carries 2,225 MAUDE reports, ranked #456 of 1000.

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

Event Types

Injury 2,056 (92.4%)
Malfunction 163 (7.3%)
Other 3 (0.1%)
2 (0.1%)
Death 1 (0.0%)

Patient Outcomes

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

Hospitalization 1,034 (24.5%)
R 1,033 (24.5%)
Required Intervention 955 (22.7%)
H 936 (22.2%)
135 (3.2%)
Other 88 (2.1%)
O 19 (0.5%)
Disability 7 (0.2%)
S 3 (0.1%)
L 1 (0.0%)
Death 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Mechanical Problem 742
Adverse Event Without Identified Device or Use Problem 552
Material Puncture/Hole 550
Inflation Problem 545
Fluid/Blood Leak 457
Migration 241
Nonstandard Device 115
Defective Device 105
Deflation Problem 101
Collapse 82
Inadequacy of Device Shape and/or Size 77
Air/Gas in Device 65
Malposition of Device 61
Degraded 55
Insufficient Information 44
Material Deformation 34
Unintended Deflation 34
Failure to Deflate 30
Connection Problem 19
Device Contamination with Chemical or Other Material 9

Yearly Trend

94
1994: 3
95
1995: 2
99
1999: 1
04
2004: 2
05
2005: 2
06
2006: 21
09
2009: 3
10
2010: 13
11
2011: 4
12
2012: 7
13
2013: 3
14
2014: 2
15
2015: 3
16
2016: 5
17
2017: 3
18
2018: 4
19
2019: 5
20
2020: 6
21
2021: 23
22
2022: 14
23
2023: 4
24
2024: 264
25
2025: 1,637
26
2026: 194

Related Entities for Prosthesis, Penis, Inflatable

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 2,099
AMERICAN MEDICAL SYSTEMS, INC. 45
COLOPLAST A/S 22
UNKNOWN 5
AMERICAN MEDICAL SYSTEMS INC 4

Event Locations

2,146 (96.4%)
HOSPITAL 35 (1.6%)
I 22 (1.0%)
NO INFORMATION 7 (0.3%)
AMBULATORY SURGICAL FACILITY 5 (0.2%)
OTHER 4 (0.2%)
INVALID DATA 3 (0.1%)
HOME 2 (0.1%)
NOT APPLICABLE 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, Penis, Inflatable, 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 (2,225 here).

Catheter, Intravascular Occluding, Temporary 2,232 Catheter, Peritoneal, Long-Term Indwelling 2,240 Prosthesis 2,198 Endoscopic Grasping/Cutting Instrument 2,195

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Prosthesis, Penis, Inflatable 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 Prosthesis, Penis, Inflatable; 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.