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.
FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §876.3350 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Prosthesis, Penis, Inflatable LIGHT-BOOK · MAUDE
#424 of 1000 · 2,835 reports · 1994–2026
- BOOK 2,835 reports
- RANK #424 of 1000
- DEATH 1 death-typed
- INJ 2,638 injury-typed
- MALF 191 malfunction
- SPAN 1994–2026
- PEAK 2025: 1,638
- PHOTO Stent
Nearest event-volume peer: Stent, Superficial Femoral Artery, Drug-Eluting (11 report gap)
Prosthesis, Penis, Inflatable sits #424 of 1000 among tracked device types with 2,835 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
Prosthesis, Penis, Inflatable carries 93.1% INJURY-coded reports, 62.8pp 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 93.1% corpus 30.3% · above corpus mean (+62.8 pp)
- MALF 6.7% corpus 64.8% · below corpus mean (-58.1 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 97% of location-tagged rows .
Prosthesis, Penis, Inflatable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Lithotriptor
Lithotriptor, Biliary Mechanical
2,875 reports
- Pin
Pin, Fixation, Smooth
2,868 reports
- Instrument
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
2,859 reports
- Nebulizer
Nebulizer (Direct Patient Interface)
2,847 reports
- Stent
Stent, Superficial Femoral Artery, Drug-Eluting
2,846 reports
- Prosthesis (this)
Prosthesis, Penis, Inflatable
2,835 reports
What this shows Prosthesis, Penis, Inflatable carries 2,835 MAUDE reports, ranked #424 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 rose to 1,638 in 2025, up from an average of 135 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Prosthesis, Penis, Inflatable
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, Penis, Inflatable: 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 (2,835 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, 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.