Implanted Fecal Incontinence Device
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 MAUDE casebook
openFDA event book Implanted Fecal Incontinence Device LIGHT-BOOK · MAUDE
#939 of 1000 · 436 reports · 1994–2024
- BOOK 436 reports
- RANK #939 of 1000
- DEATH 0 death-typed
- INJ 326 injury-typed
- MALF 105 malfunction
- SPAN 1994–2024
- PEAK 2010: 215
- PHOTO Condenser
Nearest event-volume peer: Condenser, Heat And Moisture (Artificial Nose) (1 report gap)
Implanted Fecal Incontinence Device sits #939 of 1000 among tracked device types with 436 MAUDE reports spanning 1994–2024. 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
Implanted Fecal Incontinence Device carries 74.8% INJURY-coded reports, 44.5pp 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 74.8% corpus 30.3% · above corpus mean (+44.5 pp)
- MALF 24.1% corpus 64.8% · below corpus mean (-40.7 pp)
Lead product-problem code Insufficient Device Problem Information is 30% of coded problems · Lead manufacturer AMERICAN MEDICAL SYSTEMS, INC. accounts for 100% of manufacturer-tagged reports · Top event location is 92% of location-tagged rows .
Implanted Fecal Incontinence Device in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Lithotriptor
Lithotriptor, Electro-Hydraulic
438 reports
- Stimulator
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
438 reports
- Implanted Fec… (this)
Implanted Fecal Incontinence Device
436 reports
- Condenser
Condenser, Heat And Moisture (Artificial Nose)
435 reports
- Tape
Tape, Measuring, Rulers And Calipers
435 reports
- Arterial Bloo…
Arterial Blood Sampling Kit
433 reports
What this shows Implanted Fecal Incontinence Device carries 436 MAUDE reports, ranked #939 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 4 in 2018, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Implanted Fecal Incontinence Device
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Implanted Fecal Incontinence Device carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (436 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Implanted Fecal Incontinence Device 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 Implanted Fecal Incontinence Device; 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.