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.
FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §876.3350 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Device, Impotence, Mechanical/Hydraulic MID-BOOK · MAUDE
#89 of 1000 · 38,353 reports · 1993–2026
- BOOK 38,353 reports
- RANK #89 of 1000
- DEATH 9 death-typed
- INJ 34,812 injury-typed
- MALF 3,379 malfunction
- SPAN 1993–2026
- PEAK 1997: 4,323
- PHOTO Filter
Nearest event-volume peer: Filter, Intravascular, Cardiovascular (33 report gap)
Device, Impotence, Mechanical/Hydraulic sits #89 of 1000 among tracked device types with 38,353 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 →
Injury-coded reports run above the device-type norm
Device, Impotence, Mechanical/Hydraulic carries 90.8% INJURY-coded reports, 60.5pp 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 90.8% corpus 30.3% · above corpus mean (+60.5 pp)
- MALF 8.8% corpus 64.8% · below corpus mean (-56.0 pp)
Lead product-problem code Fluid/Blood Leak is 14% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 50% of manufacturer-tagged reports · Top event location is 49% 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
- Plate
Plate, Fixation, Bone
38,818 reports
- Mesh
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
38,646 reports
- Device (this)
Device, Impotence, Mechanical/Hydraulic
38,353 reports
- Filter
Filter, Intravascular, Cardiovascular
38,320 reports
- Insulin Pump…
Insulin Pump Secondary Display
38,005 reports
- Hexokinase
Hexokinase, Glucose
37,534 reports
What this shows Device, Impotence, Mechanical/Hydraulic carries 38,353 MAUDE reports, ranked #89 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 (2,575) held close to the prior two-year average of 3,876.
Related Entities for Device, Impotence, Mechanical/Hydraulic
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Device, Impotence, Mechanical/Hydraulic: 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 (38,353 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9 here), distinct from the volume row.
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.