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.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §876.3630 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Prosthesis, Penile LIGHT-BOOK · MAUDE
#428 of 1000 · 2,754 reports · 1992–2026
- BOOK 2,754 reports
- RANK #428 of 1000
- DEATH 1 death-typed
- INJ 2,496 injury-typed
- MALF 236 malfunction
- SPAN 1992–2026
- PEAK 2019: 221
- PHOTO Real Time Nucleic Aci…
Nearest event-volume peer: Real Time Nucleic Acid Amplification System (8 report gap)
Prosthesis, Penile sits #428 of 1000 among tracked device types with 2,754 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 →
Injury-coded reports run above the device-type norm
Prosthesis, Penile carries 90.6% INJURY-coded reports, 60.3pp 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 90.6% corpus 30.3% · above corpus mean (+60.3 pp)
- MALF 8.6% corpus 64.8% · below corpus mean (-56.3 pp)
Lead product-problem code Insufficient Device Problem Information is 36% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 52% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .
Prosthesis, Penile in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Catheter And…
Catheter And Tip, Suction
2,781 reports
- Radioimmunoas…
Radioimmunoassay, Thyroid-Stimulating Hormone
2,771 reports
- Separator
Separator, Automated, Blood Cell And Plasma, Therapeutic
2,769 reports
- Prosthesis (this)
Prosthesis, Penile
2,754 reports
- Real Time Nuc…
Real Time Nucleic Acid Amplification System
2,746 reports
- System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
2,731 reports
What this shows Prosthesis, Penile carries 2,754 MAUDE reports, ranked #428 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (197) held close to the prior two-year average of 174.
Related Entities for Prosthesis, Penile
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs AMERICAN MEDICAL SYSTEMS, INC. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Prosthesis, Penile: 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 (2,754 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
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.