PlainHospital
2026 data FDA MAUDE openFDA

Prosthesis, Penile

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Prosthesis, Penile LIGHT-BOOK · MAUDE

#425 of 1000 · 2,664 reports · 1992–2026

  • BOOK 2,664 reports
  • RANK #425 of 1000
  • DEATH 1 death-typed
  • INJ 2,407 injury-typed
  • MALF 235 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 221
  • PHOTO Nebulizer

Nearest event-volume peer: Nebulizer (Direct Patient Interface) (7 report gap)

Prosthesis, Penile sits #425 of 1000 among tracked device types with 2,664 MAUDE reports spanning 1992–2026. 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 90.4% corpus 30.4% · above corpus mean (+59.9 pp)
  • MALF 8.8% corpus 64.5% · below corpus mean (-55.7 pp)

Lead product-problem code Insufficient Information is 36% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 51% of manufacturer-tagged reports · Top event location is 46% of location-tagged rows .

Prosthesis, Penile in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Penile carries 2,664 MAUDE reports, ranked #425 of 1000.

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

Event Types

Injury 2,407 (90.4%)
Malfunction 235 (8.8%)
Other 12 (0.5%)
9 (0.3%)
Death 1 (0.0%)

Patient Outcomes

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

Hospitalization 1,639 (36.0%)
R 1,565 (34.3%)
Required Intervention 568 (12.5%)
Other 256 (5.6%)
H 251 (5.5%)
174 (3.8%)
O 56 (1.2%)
Disability 15 (0.3%)
S 12 (0.3%)
L 11 (0.2%)
Invalid Data 8 (0.2%)
Life Threatening 2 (0.0%)
D 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Insufficient Information 611
Adverse Event Without Identified Device or Use Problem 450
Inadequacy of Device Shape and/or Size 125
Mechanical Problem 114
Defective Device 91
Migration 78
Fracture 45
Malposition of Device 39
Break 30
Device Operates Differently Than Expected 27
Migration or Expulsion of Device 16
Material Puncture/Hole 14
Appropriate Term/Code Not Available 11
Use of Device Problem 11
Device Appears to Trigger Rejection 9
Fluid/Blood Leak 8
Positioning Problem 8
Material Erosion 7
Nonstandard Device 7
Extrusion 6

Yearly Trend

92
1992: 30
93
1993: 32
94
1994: 54
95
1995: 21
96
1996: 99
97
1997: 220
98
1998: 8
99
1999: 7
00
2000: 4
01
2001: 2
02
2002: 2
03
2003: 9
04
2004: 6
05
2005: 11
06
2006: 20
07
2007: 3
08
2008: 5
09
2009: 5
10
2010: 27
11
2011: 87
12
2012: 97
13
2013: 108
14
2014: 75
15
2015: 98
16
2016: 104
17
2017: 123
18
2018: 127
19
2019: 221
20
2020: 163
21
2021: 167
22
2022: 168
23
2023: 160
24
2024: 187
25
2025: 197
26
2026: 17

Related Entities for Prosthesis, Penile

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 991
AMERICAN MEDICAL SYSTEMS, INC. 599
COLOPLAST A/S 336
UNKNOWN 13

Event Locations

1,235 (46.4%)
I 884 (33.2%)
NOT APPLICABLE 254 (9.5%)
HOSPITAL 105 (3.9%)
OTHER 73 (2.7%)
HOME 50 (1.9%)
INVALID DATA 47 (1.8%)
NO INFORMATION 10 (0.4%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.1%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, Penile, 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 (2,664 here).

Nebulizer 2,671 Prosthesis, Hip, Hemi-, Femoral, Metal 2,654 Catheter And Tip, Suction 2,683 Forceps, Biopsy, Non-Electric 2,688

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, Penile 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, Penile; 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.