What are FDA adverse event reports for Implanted Fecal Incontinence Device?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Implanted Fecal Incontinence Device, there are 436 total reports including 0 death reports and 326 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Implanted Fecal Incontinence Device?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2024 data FDA MAUDE openFDA

Implanted Fecal Incontinence Device

Name: Implanted Fecal Incontinence Device - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Implanted Fecal Incontinence Device LIGHT-BOOK · MAUDE

#917 of 1000 · 436 reports · 1994–2024

BOOK 436 reports
RANK #917 of 1000
DEATH 0 death-typed
INJ 326 injury-typed
MALF 105 malfunction
SPAN 1994–2024
PEAK 2010: 215
PHOTO Shunt

Nearest event-volume peer: Shunt, Portosystemic, Endoprosthesis (2 report gap)

Implanted Fecal Incontinence Device sits #917 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 →

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 74.8% corpus 30.4% · above corpus mean (+44.3 pp)
MALF 24.1% corpus 64.5% · below corpus mean (-40.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 50% 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 .

Enzyme Linked…

440
Blood Groupin…

439
Shunt

438
Implanted Fec… (this)

436
Lithotriptor

433
Arterial Bloo…

432

What this shows Implanted Fecal Incontinence Device carries 436 MAUDE reports, ranked #917 of 1000.

Event Types

Injury 326 (74.8%)

Malfunction 105 (24.1%)

Other 3 (0.7%)

2 (0.5%)

Patient Outcomes

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

R 384 (46.7%)

Hospitalization 381 (46.3%)

Required Intervention 19 (2.3%)

12 (1.5%)

Disability 11 (1.3%)

Life Threatening 6 (0.7%)

Other 6 (0.7%)

H 1 (0.1%)

L 1 (0.1%)

O 1 (0.1%)

Death 1 (0.1%)

Yearly Trend

1994: 1

2001: 3

2005: 1

2008: 1

2009: 6

2010: 215

2011: 26

2012: 35

2013: 62

2014: 46

2015: 33

2016: 1

2017: 1

2018: 4

2024: 1

Top Manufacturers

AMERICAN MEDICAL SYSTEMS, INC. 316

Event Locations

401 (92.0%)

I 16 (3.7%)

HOSPITAL 11 (2.5%)

OTHER 6 (1.4%)

NOT APPLICABLE 2 (0.5%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Implanted Fecal Incontinence Device, 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 (436 here).

Shunt, Portosystemic, Endoprosthesis 438 Blood Grouping Reagent 439 Lithotriptor, Electro-Hydraulic 433 Arterial Blood Sampling Kit 432

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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.

Implanted Fecal Incontinence Device

Event-type mix vs corpus