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2022 data FDA MAUDE openFDA FDA Class II

Alarm, Conditioned Response Enuresis

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 §876.2040 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Alarm, Conditioned Response Enuresis LIGHT-BOOK · MAUDE

#676 of 1000 · 965 reports · 1992–2022

  • BOOK 965 reports
  • RANK #676 of 1000
  • DEATH 1 death-typed
  • INJ 803 injury-typed
  • MALF 153 malfunction
  • SPAN 1992–2022
  • PEAK 2019: 423
  • PHOTO Percutaneously Delive…

Nearest event-volume peer: Percutaneously Delivered Prostheses And Tricuspid Valves (0 report gap)

Alarm, Conditioned Response Enuresis sits #676 of 1000 among tracked device types with 965 MAUDE reports spanning 1992–2022. 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 → · Similar-volume device →

Injury-coded reports run above the device-type norm

Alarm, Conditioned Response Enuresis carries 83.2% INJURY-coded reports, 52.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 83.2% corpus 30.3% · above corpus mean (+52.9 pp)
  • MALF 15.9% corpus 64.8% · below corpus mean (-49.0 pp)

Lead product-problem code Overheating of Device is 33% of coded problems · Top event location NO INFORMATION is 99% of location-tagged rows .

Alarm, Conditioned Response Enuresis in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Alarm, Conditioned Response Enuresis carries 965 MAUDE reports, ranked #676 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 803 (83.2%)
Malfunction 153 (15.9%)
7 (0.7%)
Death 1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

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

Required Intervention 436 (39.4%)
Other 218 (19.7%)
170 (15.3%)
Hospitalization 110 (9.9%)
R 98 (8.8%)
Life Threatening 30 (2.7%)
O 23 (2.1%)
L 20 (1.8%)
S 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Overheating of Device 551
Leak/Splash 240
Temperature Problem 156
Melted 109
Burst Container or Vessel 71
Device Emits Odor 61
Noise, Audible 61
Defective Component 52
Electrical Shorting 47
Defective Device 43
Break 40
Inappropriate/Inadequate Shock/Stimulation 33
Vibration 31
Device Operates Differently Than Expected 28
Thermal Decomposition of Device 28
Material Deformation 27
Fluid/Blood Leak 25
Battery Problem 22
Material Twisted/Bent 22
Chemical Spillage 21

Yearly Trend

92
1992: 1
97
1997: 2
98
1998: 1
15
2015: 9
16
2016: 21
17
2017: 185
18
2018: 286
19
2019: 423
20
2020: 36
22
2022: 1

Reports fell to 36 in 2020, down from an average of 355 in the two years before.

Related Entities for Alarm, Conditioned Response Enuresis

Event Locations

NO INFORMATION 959 (99.4%)
3 (0.3%)
HOME 2 (0.2%)
INVALID DATA 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Alarm, Conditioned Response Enuresis: 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 (965 here).

Percutaneously Delivered Prostheses And Tri… 965 Pump, Portable, Aspiration 968 Recorder, Magnetic Tape, Medical 962 Material, Tooth Shade, Resin 961

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Aligner, Sequential 1

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Alarm, Conditioned Response Enuresis 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 Alarm, Conditioned Response Enuresis; 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.